Hydrazone Colorimetry, Alt/Sgpt
FDA product code CKD · Class I (low risk) · 21 CFR 862.1030 · Clinical Chemistry
11510(k) clearances
0PMA approvals
1recalls
Manufacturers
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991834 | Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772CKD · Traditional | Cholestech Corp. | 09/09/1999SE |
| K941192 | Ortho Alt Microwell Test SystemCKD · Traditional | Ortho Diagnostic Systems, Inc. | 05/16/1995SE |
| K896237 | Cobas Ready Alt ReagentCKD · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K884784 | Virgo(R) Microwell Alt AssayCKD · Traditional | Electro-Nucleonics, Inc. | 12/29/1988SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | Tech-Co, Inc. | 10/13/1988SE |
| K864082 | Reflotron(R) Alt (GPT)CKD · Traditional | Boehringer Mannheim Corp. | 12/04/1986SE |
| K860485 | SGPT (Alt) Reagent Set (Colorimetric)CKD · Traditional | Sterling Diagnostics, Inc. | 04/03/1986SE |
| K844283 | SGPT Reagent SetCKD · Traditional | Livonia Diagnostics, Inc. | 11/27/1984SE |
| K841059 | SGPT Reagent SetCKD · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821207 | SGPT Reagent SetCKD · Traditional | Omega Medical Electronics | 07/14/1982SE |
| K820491 | SGPT Reagent SetCKD · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-1139-2013 Class II | Alere Cholestech LDX ALT AST Test Cassette, Model #12-788. For the in vitro quantitative…The recall was initiated because Alere San Diego has an update for the Alere Cholestech LDX ALT AST… | Alere San Diego, Inc. | 03/06/2013Terminated |