CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
FDA 510(k) clearance K991834 · decided 1999-09-09
Clearance details
- K-number
- K991834
- Device name
- CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772
- Applicant
- Cholestech Corp.
- Decision
- Substantially Equivalent
- Date received
- 1999-05-28
- Decision date
- 1999-09-09
- Days to decision
- 104 days
- Clearance type
- Traditional
- Product code
- CKD
- Device class
- 1
- Regulation number
- 862.1030
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Hayward, 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 |
|---|---|---|
| ORTHO ALT MICROWELL TEST SYSTEM (K941192) | Ortho Diagnostic Systems, Inc. | 1995-05-16 |
| COBAS READY ALT REAGENT (K896237) | Roche Diagnostic Systems, Inc. | 1990-02-16 |
| VIRGO(R) MICROWELL ALT ASSAY (K884784) | Electro-Nucleonics, Inc. | 1988-12-29 |
| ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) (K883387) | Tech-Co, Inc. | 1988-10-13 |
| REFLOTRON(R) ALT (GPT) (K864082) | Boehringer Mannheim Corp. | 1986-12-04 |
| SGPT (ALT) REAGENT SET (COLORIMETRIC) (K860485) | Sterling Diagnostics, Inc. | 1986-04-03 |
| SGPT REAGENT SET (K844283) | Livonia Diagnostics, Inc. | 1984-11-27 |
| SGPT REAGENT SET (K841059) | Medical Specialties, Inc. | 1984-05-01 |
| SGPT REAGENT SET (K821207) | Omega Medical Electronics | 1982-07-14 |
| SGPT REAGENT SET (K820491) | Anco Medical Reagents & Assoc. | 1982-03-11 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative d recall (Z-1139-2013) | Alere San Diego, Inc. | 2013-04-17 |