CARESIDE CKMB
FDA 510(k) clearance K990434 · decided 1999-04-19
Clearance details
- K-number
- K990434
- Device name
- CARESIDE CKMB
- Applicant
- Careside, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1999-02-11
- Decision date
- 1999-04-19
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- JHS
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Culver City, CA, 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 |
|---|---|---|
| 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 |
| 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 |
| ROCHE ISOMUNE- CK (K903025) | Roche Diagnostic Systems, Inc. | 1990-08-09 |
Recalls involving this device
No recalls on record reference this clearance.