STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
FDA 510(k) clearance K900806 · decided 1990-03-23
Clearance details
- K-number
- K900806
- Device name
- STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY
- Applicant
- Baxter Healthcare Corp
- Decision
- Substantially Equivalent
- Date received
- 1990-02-21
- Decision date
- 1990-03-23
- Days to decision
- 30 days
- Clearance type
- Traditional
- Product code
- JHS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Miami, FL, US
- Third-party review
- No
- Expedited review
- No
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| Creatine Kinase (K160570) | Roche Diagnostics Operations (Rdo) | 2016-05-25 |
| CKMB UDR ASSAY (K102706) | SENTINEL CH. SpA | 2011-08-19 |
| S40 CREATINE KINASE (CK) (K082226) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-09-18 |
| THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS (K062128) | Dade Behring, Inc. | 2006-08-21 |
| CARESIDE CK (K990439) | Careside, Inc. | 1999-04-19 |
| CARESIDE CKMB (K990434) | Careside, Inc. | 1999-04-19 |
| IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) (K981495) | Diagnostic Products Corp. | 1998-06-10 |
| ACS CKMB II IMMUNOASSAY (K962126) | Ciba Corning Diagnostics Corp. | 1996-06-21 |
| STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT (K952250) | Dade Intl., Inc. | 1995-07-17 |
| ACCESS CK-MB REAGENTS (K945083) | Bio-Rad Laboratories, Inc. | 1994-11-21 |
| KINASE ISOENZYME (K943024) | Dupont Medical Products | 1994-08-02 |
| CREATINE KINASE METHOD (K941584) | Dupont Medical Products | 1994-07-06 |
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 |