AIA-PACK CPR ASSAY
FDA 510(k) clearance K951848 · decided 1996-02-13
Clearance details
- K-number
- K951848
- Device name
- AIA-PACK CPR ASSAY
- Applicant
- Tosoh Medics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1995-04-21
- Decision date
- 1996-02-13
- Days to decision
- 298 days
- Clearance type
- Traditional
- Product code
- JKD
- Device class
- 1
- Regulation number
- 862.1135
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Foster City, CA, US
- Third-party review
- No
- Expedited review
- No
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| 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.