FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECT BILIRUBIN REAGENT
K Number: K893730
·
Decision Aug 11, 1989
Classifications
1
FEI Numbers
52
Registration Numbers
52
Same Product Code
233
Applicant Total
107
Review Days
86
Basic Information
- Device Name
- DIRECT BILIRUBIN REAGENT
- K Number
- K893730
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1110
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- MEDICAL ANALYSIS SYSTEMS, INC.
- Date Received
- May 17, 1989
- Decision Date
- August 11, 1989
- Product Code
- CIG
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| CIG | Diazo Colorimetry, Bilirubin | FDA class 2 | 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 |
| K031392 | MAS TOX AMMONIA CONTROLLIQUID ASSAYED TOX AMMONIA CONTROL | Jul 1, 2003 | Substantially Equivalent |
| K031441 | URICHEMTRAK LIQUID ASSAYED URINE 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 |