FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
AMYLOCHROME STAT SEPARATOR, TEST
K Number: K790485
·
Decision May 3, 1979
Classifications
1
FEI Numbers
218
Registration Numbers
218
Same Product Code
235
Applicant Total
49
Review Days
52
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Basic Information
- Device Name
- AMYLOCHROME STAT SEPARATOR, TEST
- K Number
- K790485
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1675
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hoffmann-La Roche, Inc.
- Date Received
- March 12, 1979
- Decision Date
- May 3, 1979
- Product Code
- JKA
- 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 |
|---|---|---|---|
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | FDA class 2 | Clinical Chemistry |
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|---|---|---|---|
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| 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 |
| K823579 | COBAS REAGENT FOR TOTAL PROTEIN | Jan 7, 1983 | Substantially Equivalent |