CKD — Hydrazone Colorimetry, Alt/Sgpt Class I
FDA product code CKD covers "Hydrazone Colorimetry, Alt/Sgpt", a Class I medical device regulated under 21 CFR 862.1030. Submissions are reviewed by the Clinical Chemistry panel. At least 11 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CKD
- Device Class
- Class I
- Regulation Number
- 862.1030
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K991834 | cholestech | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | September 9, 1999 |
| K941192 | ortho diagnostic systems | ORTHO ALT MICROWELL TEST SYSTEM | May 16, 1995 |
| K896237 | roche diagnostic systems | COBAS READY ALT REAGENT | February 16, 1990 |
| K884784 | electro-nucleonics | VIRGO(R) MICROWELL ALT ASSAY | December 29, 1988 |
| K883387 | tech-co | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | October 13, 1988 |
| K864082 | boehringer mannheim | REFLOTRON(R) ALT (GPT) | December 4, 1986 |
| K860485 | sterling diagnostics | SGPT (ALT) REAGENT SET (COLORIMETRIC) | April 3, 1986 |
| K844283 | livonia diagnostics | SGPT REAGENT SET | November 27, 1984 |
| K841059 | medical specialties | SGPT REAGENT SET | May 1, 1984 |
| K821207 | omega medical electronics | SGPT REAGENT SET | July 14, 1982 |
| K820491 | anco medical reagents and assoc | SGPT REAGENT SET | March 11, 1982 |