FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS REAGENT FOR CREATININE
K Number: K823573
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
156
Applicant Total
49
Review Days
32
Basic Information
- Device Name
- COBAS REAGENT FOR CREATININE
- K Number
- K823573
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1225
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- HOFFMANN-LA ROCHE, INC.
- Date Received
- December 6, 1982
- Decision Date
- January 7, 1983
- Product Code
- CGX
- 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 |
|---|---|---|---|
| CGX | Alkaline Picrate, Colorimetry, Creatinine | FDA class 2 | Clinical Chemistry |
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Other Clearances by HOFFMANN-LA ROCHE, INC.
| K Number | Device Name | ||
|---|---|---|---|
| K850727 | BHCG-ROCHE EIA | Jun 25, 1985 | Substantially Equivalent |
| K831694 | RENAK | Jul 19, 1983 | Substantially Equivalent |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Mar 24, 1983 | Substantially Equivalent |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | Mar 24, 1983 | Substantially Equivalent |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Mar 24, 1983 | Substantially Equivalent |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Mar 24, 1983 | Substantially Equivalent |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Mar 24, 1983 | Substantially Equivalent |
| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Mar 24, 1983 | Substantially Equivalent |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Mar 10, 1983 | Substantially Equivalent |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | Jan 7, 1983 | Substantially Equivalent |