FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COBAS REAGENT FOR TOTAL PROTEIN
K Number: K823579
·
Decision Jan 7, 1983
Classifications
1
FEI Numbers
42
Registration Numbers
42
Same Product Code
115
Applicant Total
49
Review Days
32
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Basic Information
- Device Name
- COBAS REAGENT FOR TOTAL PROTEIN
- K Number
- K823579
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1635
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hoffmann-La Roche, Inc.
- Date Received
- December 6, 1982
- Decision Date
- January 7, 1983
- Product Code
- CEK
- 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 |
|---|---|---|---|
| CEK | Biuret (Colorimetric), Total Protein | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CEK), ordered by most recent decision date.
HICHEM TOTAL PROTEIN REAGENT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN (MICRO) ASSAY, CATALOGUE NUMBER 450-50
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CARESIDE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TOTAL PROTEIN OR TP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
CSF/URINE TOTAL PROTEIN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
STC DIAGNOSTICS AUTO-LYTE URINARY PROTEIN ASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
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| K830480 | ABUSCREEN RADIOIMMUNOASSAY-COCAINE META | Mar 24, 1983 | Substantially Equivalent |
| K830461 | ABUSCREEN RADIOUMMUNOASSAY-METHAQUALONE | Mar 24, 1983 | Substantially Equivalent |
| K830460 | ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE | Mar 24, 1983 | Substantially Equivalent |
| K830482 | ABUSCREEN RADIOIMMUNOASSAY-AMPHETAMINE | Mar 24, 1983 | Substantially Equivalent |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Mar 24, 1983 | Substantially Equivalent |
| K830479 | ABUSCREEN RADIOIMMUNOASSAY-BARBITURATE | Mar 10, 1983 | Substantially Equivalent |
| K823578 | COBAS STANDARDS FOR CALCIUM-IN-ORGANIC | Jan 7, 1983 | Substantially Equivalent |