N-ASSAY TIA APO B TEST KIT
FDA 510(k) clearance K964296 · decided 1997-08-01
Clearance details
- K-number
- K964296
- Device name
- N-ASSAY TIA APO B TEST KIT
- Applicant
- Crestat Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1996-10-29
- Decision date
- 1997-08-01
- Days to decision
- 276 days
- Clearance type
- Traditional
- Product code
- DER
- Device class
- 2
- Regulation number
- 866.5580
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Murrieta, 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 |
|---|---|---|
| TINA-QUANT APOLIPOPROTEIN VER.2 (K013249) | Roche Diagnostics Corp. | 2001-11-16 |
| BAYER ADVIA IMS SYSTEM; 200 + 3 (K000921) | Bayer Corp. | 2000-05-18 |
| K-ASSAY APO B (K993354) | Kamiya Biomedical Co. | 1999-10-28 |
| K-ASSAY APO AI (K993345) | Kamiya Biomedical Co. | 1999-10-25 |
| INTEGRA REAGENT CASSETTE FOR APOLIPOPROTEIN A-1 (K990594) | Roche Diagnostics Corp. | 1999-04-14 |
| APOLIPOPROTEIN A1 (K983289) | Abbott Laboratories | 1999-01-29 |
| N-ASSAY TIA APO A1/B MULTI CALIBRATOR (K964294) | Crestat Diagnostics, Inc. | 1997-08-01 |
| N-ASSAY TIA APO A1 TEST KIT (K964292) | Crestat Diagnostics, Inc. | 1997-08-01 |
| ROCHE APOLIPOPROTEIN STANDARD (K910553) | Roche Diagnostic Systems, Inc. | 1991-05-08 |
| UC IMU A (K904125) | Eucardio Laboratory, Inc. | 1990-09-24 |
| QC3 WHOLE HUMAN SERUM, HDL-CHOLESTEROL CONTROL (K872078) | Solomon Park Research Laboratories | 1987-06-18 |
| APO-SCREEN CALIBRATOR & CONTROL SET FOR HDL APO A1 (K854875) | Photec Diagnostics, Inc. | 1986-01-24 |
Recalls involving this device
No recalls on record reference this clearance.