Product Code: LRJ
FDA class 1
21 CFR 880.6890
Disinfectant, Medical Devices
General Hospital
Medical device disinfectants are chemical agents specifically formulated and intended for the cleaning and disinfection of reusable medical devices, reducing microbial contamination to safe levels between patient uses. They are classified as a Class 1 (lowest risk) device, subject only to general controls, representing the least burdensome regulatory category. The product code is LRJ, regulated under 21 CFR 880.6890, within the General Hospital medical specialty. No special flags apply to this device.
510(k)s
73
FEI Numbers
386
Registration Numbers
386
Unique Applicants
34
Years Active
12
Basic Information
- Product Code
- LRJ
- Device Class
- FDA class 1
- Regulation Number
- 880.6890
- Medical Specialty
- General Hospital
- Review Panel
- HO
- Submission Type
- 4
Device Characteristics
✗
GMP Exempt
✗
Implant
✗
Life Sustain/Support
✗
Third Party
—
Summary Malfunction Reporting
510(k) Clearance History
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Related 510(k) Clearances
This FDA classification is associated with 73 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K992661 | CONTROL III ELITE | Sep 14, 1999 | Substantially Equivalent | MARIL PRODUCTS, INC. |
| K991509 | PRO-PORTION CLEANER/DISINFECTANT | Jul 14, 1999 | Substantially Equivalent | SULTAN CHEMISTS, INC. |
| K984485 | MICROSTAT 2 | Jan 13, 1999 | Substantially Equivalent | CHEMLINK LABORATORIES LLC. |
| K983947 | AMERSE 2 | Dec 04, 1998 | Substantially Equivalent | STERIS Corporation |
| K983869 | DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH | Nov 30, 1998 | Substantially Equivalent | CALTECH INDUSTRIES, INC. |
| K983585 | LOW PH PHENOLIC 256 | Nov 06, 1998 | Substantially Equivalent | CENTRAL SOLUTIONS, INC. |
| K982985 | CITREX HOSPITAL SPRAY DISINFECTANT | Nov 02, 1998 | Substantially Equivalent | CALTECH INDUSTRIES, INC. |
| K981023 | KLEENASEPTIC | Apr 30, 1998 | Substantially Equivalent | METREX RESEARCH CORP. |
| K980369 | T.B.Q. RTU | Feb 17, 1998 | Substantially Equivalent | STERIS Corporation |
| K974304 | GERMICIDAL CLOTH | Jan 13, 1998 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K961044 | NOVIGUARD QUICK DRY | Jul 03, 1997 | Substantially Equivalent | DR. NOVIS SMITH & CO., INC. |
| K970825 | BLUE CHIP GERMICIDAL CLEANER & DEODORANT | Mar 14, 1997 | Substantially Equivalent | S.C. JOHNSON PROFESSIONAL |
| K964376 | CIDE-SWIPES P-100B & CIDE-SWIPES C-100A | Dec 23, 1996 | Substantially Equivalent | MP SCIENTIFIC, INC. |
| K964828 | VIREX II 128 GERMICIDAL CLEANER AND DEODORANT | Dec 19, 1996 | Substantially Equivalent | S.C. JOHNSON & SON, INC. |
| K964835 | COVERAGE SPRAY HBV | Dec 16, 1996 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K964749 | COVERAGE HBV | Dec 13, 1996 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K964613 | VIREX II 256 GERMICIDAL CLEANER AND DEODORANT | Dec 13, 1996 | Substantially Equivalent | S.C. JOHNSON & SON, INC. |
| K964610 | TRIAD II DISINFECTANT CLEANER AND DEODORANT | Dec 13, 1996 | Substantially Equivalent | S.C. JOHNSON & SON, INC. |
| K964535 | VIREX TB READY-TO-USE DSINFECTANT CLEANER & DEODORANT | Dec 13, 1996 | Substantially Equivalent | S.C. JOHNSON & SON, INC. |
| K963353 | LYSOL I.C. BRAND PHENOLIC DISINFECTANT CLEANER (EPA REG. NO. 675-46) | Oct 18, 1996 | Substantially Equivalent | RECKITT BENCKISER, INC. |
| K962739 | T.B.Q. | Oct 07, 1996 | Substantially Equivalent | CONVATEC, A DIVISION OF E.R. SQUIBB & SONS |
| K960836 | DMS-9000 | Sep 12, 1996 | Substantially Equivalent | O.R. SOLUTIONS, INC. |
| K960583 | MATAR GENERAL PURPOSE DISINFECTANT | Mar 12, 1996 | Substantially Equivalent | HUNTINGTON LABORATORIES, INC. |
| K960582 | ASCEND GENERAL PURPOSE DISINFECTANT | Mar 12, 1996 | Substantially Equivalent | HUNTINGTON LABORATORIES, INC. |
| K960580 | BEAUCOUP GENERAL PURPOSE DISINFECTANT | Mar 12, 1996 | Substantially Equivalent | HUNTINGTON LABORATORIES, INC. |
| K955850 | PRO-TECH | Feb 09, 1996 | Substantially Equivalent | CENTRAL SOLUTIONS, INC. |
| K923693 | KLORMAN | Jan 23, 1996 | Substantially Equivalent | MATRIX MEDICA, INC. |
| K934150 | BIOCIDE CLEANER/DISINFECTANT | Dec 06, 1995 | Substantially Equivalent | JUAN SIERRA |
| K934014 | VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANT | Dec 06, 1995 | Substantially Equivalent | BIOTROL, USA, INC. |
| K952929 | LD GENERAL PURPOSE DISINFECTANT | Oct 07, 1995 | Substantially Equivalent | ALCIDE CORP. |
| K953241 | EXSPOR | Sep 29, 1995 | Substantially Equivalent | ALCIDE CORP. |
| K954292 | Q5. 5-5.5NPB-2.5HW | Sep 27, 1995 | Substantially Equivalent | CENTRAL SOLUTIONS, INC. |
| K952405 | CITRACE HOSPITAL GERMICIDAL DEODORIZER | Aug 28, 1995 | Substantially Equivalent | CALTECH INDUSTRIES, INC. |
| K952336 | DISPATCH HOSPITAL CLEANER DISINFECTANT WITH BLEACH | Aug 28, 1995 | Substantially Equivalent | CALTECH INDUSTRIES, INC. |
| K951020 | TRI-CEN GERMICIDAL DETERGENT | Aug 28, 1995 | Substantially Equivalent | CENTRAL SOLUTIONS, INC. |
| K953011 | FORMULATION HWS-64 EPA REG. NO. 47371-131 | Aug 11, 1995 | Substantially Equivalent | HUNTINGTON LABORATORIES, INC. |
| K953010 | FORMULATION HWS-256 EPA REG. NO. 47371-129 | Aug 11, 1995 | Substantially Equivalent | HUNTINGTON LABORATORIES, INC. |
| K953009 | FORMULATION HWS-128 EPA REG. NO. 47371-130 | Aug 11, 1995 | Substantially Equivalent | HUNTINGTON LABORATORIES, INC. |
| K951512 | PRECISE HOSPITAL FOAM CLEANER DISINFECTANT | Aug 07, 1995 | Substantially Equivalent | CALTECH INDUSTRIES, INC. |
| K952302 | AMUCHINA | Jul 26, 1995 | Substantially Equivalent | AMUCHINA INTL., INC. |
| K951162 | PHENO-CEN GERMICIDAL DETERGENT | Jul 11, 1995 | Substantially Equivalent | CENTRAL SOLUTIONS, INC. |
| K941439 | RENALIN COLD STERILANT | Jun 26, 1995 | Substantially Equivalent | MINNTECH CORP. |
| K951983 | IMNI-II | Jun 20, 1995 | Substantially Equivalent | COTTRELL, LTD. |
| K951342 | Q4.5-5.0PB-4.5 | Apr 25, 1995 | Substantially Equivalent | CENTRAL SOLUTIONS, INC. |
| K951317 | PHENO-CEN SPRAY DISINFECTANT DEODORANT | Apr 25, 1995 | Substantially Equivalent | CENTRAL SOLUTIONS, INC. |
| K951123 | CAVICIDE SURFACE DISINFECTANT/DECONTAMINANT CLEANER | Apr 25, 1995 | Substantially Equivalent | MICRO-ASEPTIC PRODUCTS, INC. |
| K940382 | LYSOL I.C. BRAND DISINFECTANT | Apr 21, 1995 | Substantially Equivalent | NATIONAL LABORATORIES |
| K946078 | HOSPITAL BROAD BAND CLEANDR - DISINFECTANT-DEODORANT | Mar 24, 1995 | Substantially Equivalent | CLARIANT CORPORATION |
| K945227 | OCIDE HOSPITAL CLEANER-DISINFECTANT | Mar 23, 1995 | Substantially Equivalent | CLARIANT CORPORATION |
| K950553 | COLDCIDE-2 | Mar 22, 1995 | Substantially Equivalent | METREX RESEARCH CORP. |
| K950516 | COLDCIDE-10 | Mar 22, 1995 | Substantially Equivalent | METREX RESEARCH CORP. |
| K950324 | MULTI-WASH | Mar 22, 1995 | Substantially Equivalent | MULTI-WASH MEDICAL, LTD. |
| K944179 | CONTROL III DISINFECTANT GERMICIDE | Mar 22, 1995 | Substantially Equivalent | MARIL PRODUCTS, INC. |
| K944037 | DIACIDE HD DISINFECTING SOLUTION | Mar 22, 1995 | Substantially Equivalent | GULFSTREAM MEDICAL |
| K940383 | LYSOL I.C. BRAND INSTRUMENT DISINFECTANT PRESOAK | Mar 22, 1995 | Substantially Equivalent | NATIONAL LABORATORIES |
| K940400 | LYSOL I.C. BRAND DISINFECTANT SPRAY | Jul 25, 1994 | Substantially Equivalent | L&F PRODUCTS |
| K940381 | LYSOL I.C. BRAND QUATERNARY CLEANER DISINFECTANT | Jul 25, 1994 | Substantially Equivalent | NATIONAL LABORATORIES |
| K931477 | AMERSE | Jun 17, 1994 | Substantially Equivalent | CALGON VESTAL DIV. |
| K931816 | VESTA-SYDE(R) INTERIM INSTR DECONTAMINATION SYSTEM | May 26, 1994 | Substantially Equivalent | CALGON VESTAL DIV. |
| K931342 | LPH | May 26, 1994 | Substantially Equivalent | CALGON VESTAL DIV. |
| K931573 | VESPHENE II | May 16, 1994 | Substantially Equivalent | CALGON VESTAL DIV. |
| K932502 | LONZA FORMULATION R-82 | May 12, 1994 | Substantially Equivalent | LONZA, INC. |
| K932277 | LONZA FORMULATION R-82 | May 12, 1994 | Substantially Equivalent | CALGON VESTAL DIV. |
| K924434 | CIDEX ACTIVATED DIALDEHYDE SOLUTION | Mar 29, 1994 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K923744 | CIDEX PLUS 28 DAY SOLUTION | Mar 29, 1994 | Substantially Equivalent | JOHNSON & JOHNSON MEDICAL, INC. |
| K926013 | SPORICIDIN BRAND DISINFECT TOWEL, SPRAY/SOLUT MODI | Feb 12, 1993 | Substantially Equivalent | SPORICIDIN INTL. |
| K922262 | SPORICIDIN BRAND DISINFECT TOWELETTES/SPRAY/SOLUT | Sep 15, 1992 | Substantially Equivalent for Some Indications | SPORICIDIN INTL. |
| K904581 | SPORICIDIN BRAND DISINFECTANT SOLUTION | May 18, 1992 | Substantially Equivalent | SPORICIDIN INTL. |
| K904580 | SPORICIDIN BRAND DISINFECTANT SPRAY | May 18, 1992 | Substantially Equivalent | SPORICIDIN INTL. |
| K904579 | SPORICIDIN BRAND DISINFECTANT TOWELETTES | May 18, 1992 | Substantially Equivalent | SPORICIDIN INTL. |
| K882564 | RENALIN COLD STERILANT | Jan 09, 1989 | Substantially Equivalent | MINNTECH CORP. |
| K870759 | CLEANING SOLUTION, CATALOG NO. 8203 | May 07, 1987 | Substantially Equivalent | TREACE MEDICAL, INC. |
| K870276 | HEATED INSTRUMENT BATH | May 07, 1987 | Substantially Equivalent | SIMPSON/BASYE, INC. |
FEI Numbers
This FDA classification entry is associated with 386 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 386 registration numbers. Click on an entry to view related FDA registrations.