FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HUMAN PLASMA CONTROL FOR CEA-ROCHE
K Number: K822219
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
492
Applicant Total
49
Review Days
155
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Basic Information
- Device Name
- HUMAN PLASMA CONTROL FOR CEA-ROCHE
- K Number
- K822219
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hoffmann-La Roche, Inc.
- Date Received
- July 26, 1982
- Decision Date
- December 28, 1982
- Product Code
- JJX
- 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 |
|---|---|---|---|
| JJX | Single (Specified) Analyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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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 |
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