FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BACTON TM, BASIC TM, APO B REAGENT
K Number: K893884
·
Decision Jun 21, 1989
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
41
Review Days
22
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Basic Information
- Device Name
- BACTON TM, BASIC TM, APO B REAGENT
- K Number
- K893884
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Catachem, Inc.
- Date Received
- May 30, 1989
- Decision Date
- June 21, 1989
- Product Code
- MSJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| MSJ | Apolipoproteins | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MSJ), ordered by most recent decision date.
DIAZYME APOLIPOPROTEIN A-1 ASSAY
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APOLIPOPROTEIN A1 AND APOLIPOPROTEIN B REAGENTS AND CALIBRATORS
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DIMENSION VISTA APOA1 AND APOB FLEX REAGENT CARTRIDGES AND PROTEIN 1 CALIBRATOR AND CONTROL MEDIUM AND HIGH
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8 ADDITIONAL ASSAYS FOR THE BAYER ADVIA 1650 CHEMISTRY SYSTEM
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SYNCHRON LX SYSTEMS APOLIPOPROTEIN (APOA AND APOB) REAGENTS
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Other Clearances by Catachem, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K062503 | CATACHEM, INC., BILE ACIDS REAGENTS AND/OR BILE ACIDS TEST KIT | Jan 19, 2007 | Substantially Equivalent |
| K945408 | 340-CHLORIDE FOR DISCRETE RANDOM ACCESS ANALYZER | Feb 22, 1995 | Substantially Equivalent |
| K932871 | UIBC FOR DISCREET RANDOM ACCESS ANALYZER | Sep 8, 1993 | Substantially Equivalent |
| K903341 | MAGNESIUM | Aug 22, 1990 | Substantially Equivalent |
| K902326 | AMYLASE FOR MANUAL/AUTOMATED APPLICATIONS | Jul 31, 1990 | Substantially Equivalent |
| K902877 | TOTAL IRON FOR MANUAL/AUTOMATED | Jul 27, 1990 | Substantially Equivalent |
| K895748 | BICARBONATE FOR MANUAL/AUTOMATED APPLICATIONS | Dec 21, 1989 | Substantially Equivalent |
| K895821 | URIC ACID FOR MANUAL/AUTOMATED APPLICATIONS | Dec 5, 1989 | Substantially Equivalent |
| K894715 | CREATINE KINASE FOR MANUAL/AUTOMATED APPLICATIONS | Nov 8, 1989 | Substantially Equivalent |
| K894389 | CREATININE FOR MANUAL OR AUTOMATED APPLICATIONS | Oct 12, 1989 | Substantially Equivalent |