PROTEIN BASE ISE CONTROL
FDA 510(k) clearance K880710 · decided 1988-03-24
Clearance details
- K-number
- K880710
- Device name
- PROTEIN BASE ISE CONTROL
- Applicant
- Bionostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-02-22
- Decision date
- 1988-03-24
- Days to decision
- 31 days
- Clearance type
- Traditional
- Product code
- JJR
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Acton, MA, US
- Third-party review
- No
- Expedited review
- No
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|---|---|---|
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| SWEAT CONTROLS FOR CYSTIC FIBROSIS TESTING (K943925) | Quantimetrix Corp. | 1994-10-04 |
| I-STAT CONTROL LEVELS 1,2,3 (K934641) | I-Stat Corp. | 1993-12-09 |
| ELECTROLYTE CONTROL (K912513) | Verichem Laboratories, Inc. | 1991-07-19 |
| ELECTROLYTE CONTROLS (ASSAYED AND UNASSAYED) (K902266) | Phoenix Diagnostics, Inc. | 1990-06-06 |
| CIBA CORNING CERTAIN LYTE (K894576) | Ciba Corning Diagnostics Corp. | 1989-10-30 |
| QCLYTE PROTEIN-BASED ISE CONTROL (K895582) | Baxter Healthcare Corp | 1989-10-04 |
| DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET (K881773) | Casco Standards | 1988-06-10 |
| SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL (K881655) | Biomedical Research & Development Laboratories, Inc. | 1988-05-27 |
Recalls involving this device
No recalls on record reference this clearance.