C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
FDA 510(k) clearance K833396 · decided 1984-04-13
Clearance details
- K-number
- K833396
- Device name
- C-PEPTIDE RADIOIMMUNOASSAY TEST KIT
- Applicant
- Serono Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1983-09-30
- Decision date
- 1984-04-13
- Days to decision
- 196 days
- Clearance type
- Traditional
- Product code
- JKD
- Device class
- 1
- Regulation number
- 862.1135
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Walker, MI, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| AIA-PACK CPR ASSAY (K951848) | Tosoh Medics, Inc. | 1996-02-13 |
| IMMULITE C-PEPTIDE (K943767) | Diagnostic Products Corp. | 1995-03-23 |
| DSL C-PEPTIDE RIA (DSL #7000) (K896420) | Diagnostic Systems Laboratories, Inc. | 1990-05-24 |
| DOUBLE ANTIBODY C-PEPTIDE RIA KIT (K854066) | Diagnostic Products Corp. | 1985-11-12 |
| C-PEP-RIA-100 (K842267) | Institut National Des Radioelements | 1984-09-06 |
| HUMAN C-PEPTIDE OF INSULIN BY RADIOIMM. (K820666) | Immuno Nuclear Corp. | 1982-07-13 |
| RIA QUANT C-PEPTIDE KIT (K812689) | Mallinckrodt Critical Care | 1981-10-06 |
| HUMAN C-PEPTIDE REAGENTS (K812288) | Immunex Radiochemical Diagnostics | 1981-08-31 |
| C-PEPTICE REAGENTS (K810718) | Calbiochem-Behring Corp. | 1981-03-31 |
Recalls involving this device
No recalls on record reference this clearance.