Product Code: LIB
FDA class 1
21 CFR 866.2660
Device, General Purpose, Microbiology, Diagnostic
Microbiology
A general-purpose microbiology diagnostic device encompasses a broad range of instruments, reagents, and accessories used in clinical microbiology laboratories for general diagnostic purposes, including culture media, inoculation tools, and other non-specific laboratory aids. The device is FDA Class 1, the lowest risk category, requiring only general controls and not requiring premarket notification. It bears product code LIB and is regulated under 21 CFR 866.2660 within the Microbiology specialty. No special flags apply to this device.
510(k)s
43
FEI Numbers
45
Registration Numbers
45
Unique Applicants
22
Years Active
21
Basic Information
- Product Code
- LIB
- Device Class
- FDA class 1
- Regulation Number
- 866.2660
- Medical Specialty
- Microbiology
- Review Panel
- MI
- 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 43 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K023677 | OSMETECH MICROBIAL ANALYSER-BACTERIAL VAGINOSIS (OMA-BV) | Jan 29, 2003 | Substantially Equivalent | OSMETECH |
| K920416 | SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB | Apr 08, 1992 | Substantially Equivalent | BEHRING DIAGNOSTICS, INC. |
| K912558 | GULL ELISAWARE | Sep 16, 1991 | Substantially Equivalent | GULL LABORATORIES, INC. |
| K872273 | CORNING EASY WASH ELISA PLATES | Jul 07, 1987 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K871559 | CELL LIFTER | May 15, 1987 | Substantially Equivalent | CORNING COSTAR CORP. |
| K864249 | NORMAL SALINE STERILE | Mar 31, 1987 | Substantially Equivalent | MDS LABORATORIES, INC. |
| K863789 | CORNING ELISA PLATES | Oct 03, 1986 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K862112 | MICROSCOPE SLIDES | Jun 13, 1986 | Substantially Equivalent | ABCO DEALERS, INC. |
| K854604 | AUTO MASH | Dec 06, 1985 | Substantially Equivalent | DYNATECH CORP. |
| K854603 | MULTI MASH 2000 | Dec 06, 1985 | Substantially Equivalent | DYNATECH CORP. |
| K854602 | MINI MASH 2000 | Dec 06, 1985 | Substantially Equivalent | DYNATECH CORP. |
| K854423 | IMMULON 1 EIA TUBES, IMMULON 2 EIA TUBES | Nov 20, 1985 | Substantially Equivalent | DYNATECH LABORATORIES, INC. |
| K853285 | MYWASHER 5 | Oct 04, 1985 | Substantially Equivalent | SCIENTIFIC SALES INTL., INC. |
| K853745 | MIC-CONCEPT VIEWBOX | Sep 19, 1985 | Substantially Equivalent | MICROTECH MEDICAL SYSTEMS, INC. |
| K850725 | QUADRA TITER MICRO PLATES | Apr 30, 1985 | Substantially Equivalent | MICROTECH MEDICAL SYSTEMS, INC. |
| K844476 | PORTABLE DIAGNOSTIC LABORATORY | Mar 13, 1985 | Substantially Equivalent | PORTABLE MEDICAL LABORATORIES, INC. |
| K844442 | RAPID DIAGNOSTIC KIT | Feb 01, 1985 | Substantially Equivalent | PORTABLE MEDICAL LABORATORIES, INC. |
| K844473 | HAND-HELD SLIDE READER | Jan 04, 1985 | Substantially Equivalent | PORTABLE MEDICAL LABORATORIES, INC. |
| K843483 | PHARMA-PLAST PETRI DISH | Sep 21, 1984 | Substantially Equivalent | ZIMMAR CONSULTING LTD. |
| K842052 | GIARDIA GUARD | Sep 11, 1984 | Substantially Equivalent | GELMAN SCIENCES, INC. |
| K842057 | MACLEAN-FOGG, DISPOS-INOCULA-LOOPS | Jun 07, 1984 | Substantially Equivalent | POLYMER TECHNOLOGY CORP. |
| K841632 | CODE-A-WELL SERIES 200 PLATE | May 25, 1984 | Substantially Equivalent | PLASTIC INJECTORS, INC. |
| K841937 | CODE-A-WELL SERIES 300 PLATE | May 22, 1984 | Substantially Equivalent | PLASTIC INJECTORS, INC. |
| K841390 | CODE-A-WELL | May 02, 1984 | Substantially Equivalent | PLASTIC INJECTORS, INC. |
| K833131 | HCC-MYCOBACTERIA STAIN KIT | Oct 27, 1983 | Substantially Equivalent | DR. C.V. JACOB |
| K831641 | READER MICROELISA SYSTEM | Aug 11, 1983 | Substantially Equivalent | ORGANON TEKNIKA CORP. |
| K832117 | IMMULON SUBSTRATE REMOVAWELL STRIPS | Aug 08, 1983 | Substantially Equivalent | DYNATECH CORP. |
| K831658 | MICROELISA COMP | Jul 26, 1983 | Substantially Equivalent | ORGANON TEKNIKA CORP. |
| K831643 | STRIPREADER MICROELISA SYSTEM | Jul 26, 1983 | Substantially Equivalent | ORGANON TEKNIKA CORP. |
| K831642 | HEATING BLOCK MICROELISA SYSTEM | Jul 26, 1983 | Substantially Equivalent | ORGANON TEKNIKA CORP. |
| K831448 | SPIA SYS FOR SOLID PHASE IMMUNOASSAYS | Jun 08, 1983 | Substantially Equivalent | R & D SYSTEMS, INC. |
| K831450 | DISPOSABLE STERILE FILTER SYSTEM | Jun 02, 1983 | Substantially Equivalent | CORNING MEDICAL & SCIENTIFIC |
| K823787 | HANDI-WASH | Mar 09, 1983 | Substantially Equivalent | DYNATECH CORP. |
| K823833 | MICRO STIX #011-010-5000 & HOLDER#5100 | Mar 08, 1983 | Substantially Equivalent | DYNATECH CORP. |
| K823557 | REMOVAWELL PLATE LID | Dec 28, 1982 | Substantially Equivalent | DYNATECH CORP. |
| K822962 | MICROFLUOR B REMOVAWELL STRIPS | Nov 16, 1982 | Substantially Equivalent | DYNATECH CORP. |
| K822960 | MICROFLUOR B PLATE & MICRO FLUOR W PLATE | Nov 16, 1982 | Substantially Equivalent | DYNATECH CORP. |
| K822292 | DISPOSABLE DISPENSING-SPREAD PIPETS | Aug 25, 1982 | Substantially Equivalent | AMERICAN DADE |
| K820346 | CALI-PIPETTE | Mar 04, 1982 | Substantially Equivalent | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
| K820345 | CALI-LOOP | Mar 04, 1982 | Substantially Equivalent | CARR-SCARBOROUGH MICROBIOLOGICALS, INC. |
| K820043 | TEK-PRO TEK-TATOR V ROTATOR & HUMIDIFY | Jan 28, 1982 | Substantially Equivalent | AMERICAN DADE |
| K813640 | MINIWASH II | Jan 28, 1982 | Substantially Equivalent | DYNATECH CORP. |
| K812068 | PROPOSED CONTROLS FOR DOSIMETRIC RELEASE | Sep 08, 1981 | Substantially Equivalent | HEXCEL MEDICAL |
FEI Numbers
This FDA classification entry is associated with 45 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 45 registration numbers. Click on an entry to view related FDA registrations.