QCLYTE PROTEIN-BASED ISE CONTROL
FDA 510(k) clearance K895582 · decided 1989-10-04
Clearance details
- K-number
- K895582
- Device name
- QCLYTE PROTEIN-BASED ISE CONTROL
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1989-09-15
- Decision date
- 1989-10-04
- Days to decision
- 19 days
- Clearance type
- Traditional
- Product code
- JJR
- Device class
- 1
- Regulation number
- 862.1660
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Santa Ana, CA, US
- Third-party review
- No
- Expedited review
- No
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Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| EASYLYTE QUALITY CONTROL KIT, MODELS 2814, 2815, 2816 (K990971) | Medica Corp. | 1999-04-27 |
| ELECTROLYTE STANDARDS (K960592) | Phoenix Diagnostics, Inc. | 1996-05-13 |
| RNA MEDICAL HEMAT CONTROL (K955630) | Bionostics, Inc. | 1996-03-01 |
| AALTO SCIENTIFIC SWEAT CHLORIDE REFERENCE MATERIAL (K951435) | Aalto Scientific, Ltd. | 1995-05-02 |
| 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 |
| 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 |
| PROTEIN BASE ISE CONTROL (K880710) | Bionostics, Inc. | 1988-03-24 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077) | Baxter Healthcare Corp | 2025-11-13 |
| FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076) | Baxter Healthcare Corp | 2025-06-30 |
| Floseal Hemostatic Matrix (P990009/S075) | Baxter Healthcare Corp | 2025-01-30 |
| Adept Adhesion Reduction Solution (P050011/S009) | Baxter Healthcare Corp | 2024-08-23 |
| Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074) | Baxter Healthcare Corp | 2024-08-15 |
| Floseal Hemostatic Matrix (P990009/S073) | Baxter Healthcare Corp | 2024-01-10 |
| Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072) | Baxter Healthcare Corp | 2023-12-12 |
| Floseal Hemostatic Matrix, RT5 (P990009/S070) | Baxter Healthcare Corp | 2023-02-02 |