FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
K Number: K912749
·
Decision Sep 23, 1991
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
49
Applicant Total
107
Review Days
94
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Basic Information
- Device Name
- REFLAB(TM) BR SYST PACK LIQ REAG, APOLIPOPROTEIN B
- K Number
- K912749
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Medical Analysis Systems, Inc.
- Date Received
- June 21, 1991
- Decision Date
- September 23, 1991
- 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 |
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Other Clearances by Medical Analysis Systems, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K042717 | MAS, DADE AND LIQUID ASSAYED DIABETES CONTROL | Nov 5, 2004 | Substantially Equivalent |
| K041194 | ABBOTT ARCHITECT STAT TROPONIN I LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL L, M AND H | Aug 16, 2004 | Substantially Equivalent |
| K040880 | MAS CARDIOIMMUNE TL LIQUID ASSAYED CARDIAC MARKER CONTROL, LEVELS 1,2 AND 3 | Apr 28, 2004 | Substantially Equivalent |
| K032826 | MAS PAR TDM | Oct 9, 2003 | Substantially Equivalent |
| K032335 | MAS CARDIOIMMUNE PROBNP, MAS CARDIOIMMUNE TL | Aug 19, 2003 | Substantially Equivalent |
| K031890 | MAS BILIRUBIN LIQUID ASSAYED BILIRUBIN CONTROL | Jul 16, 2003 | Substantially Equivalent |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE CONTROL | Jul 1, 2003 | Substantially Equivalent |
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Jul 1, 2003 | Substantially Equivalent |
| K031364 | MAS CARDIOLMMUNE PROBNP LIQUID ASSAYED CARDIAC MARKER CONTROL LEVEL 1, 2 AND 3 | May 30, 2003 | Substantially Equivalent |
| K030942 | MAS CHEMTRAK H & DADE MONI-TROL H LIQUID ASSAYED CHEMISTRY CONTROL | Apr 28, 2003 | Substantially Equivalent |