Centrifichem Alt/Agpt Optimized Reagent
FDA 510(k) K811694 · Baker Instructions Corp.
510(k) numberK811694
Submission
- Device name
- Centrifichem Alt/Agpt Optimized Reagent
- Applicant
- Baker Instructions Corp.
Mchenry, IL, US - Received
- June 15, 1981
- Decision date
- July 1, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…CKA · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
| K113382 | Ace Alt ReagentCKA · Traditional | Alfa Wassermann | 07/19/2012SE |
| K061020 | Dimension Vista Albumin, Alkaline Phosphatase, Aspartate Amino Transferase…CKA · Special | Dade Behring, Inc. | 05/10/2006SE |
| K020487 | Careside AltCKA · Traditional | Careside, Inc. | 06/04/2002SE |
| K980028 | Alt (GPT) Liquid Stable 2 Vial - Incorporating Dynamic Stabilization Technology - (DST)CKA · Traditional | Trace America, Inc. | 02/02/1998SE |
| K973869 | Trace Reagent Line for the Cobas MiraCKA · Traditional | Trace America, Inc. | 01/07/1998SE |
| K974003 | Alanine Aminotransferase-Sl Assay Catalogue Number 318-10, 318-30CKA · Traditional | Diagnostic Chemicals , Ltd. | 12/05/1997SE |
| K971323 | Alt or SGPTCKA · Traditional | Carolina Liquid Chemistries Corp. | 04/21/1997SE |
| K965134 | Alt/SgptCKA · Traditional | Derma Media Lab., Inc. | 02/18/1997SE |
| K961123 | Alt Incorporating DSTCKA · Traditional | Trace Scientific , Ltd. | 04/25/1996SE |
More from Trace Scientific , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K882612 | System 9000 Diff Model Automated Cell CounterGKZ · Traditional | 09/07/1988SE |
| K873596 | Baker TDM Theophylline AssayKLS · Traditional | 10/20/1987SE |
| K870603 | System 9000 Automated Cell CounterGKL · Traditional | 03/31/1987SE |
| K854173 | Ucd Urine Specimen CollectorKNX · Traditional | 11/04/1985SE |
| K850386 | System 8000 Cell CounterGKL · Traditional | 05/02/1985SE |
| K833116 | Spirit Chemistry SystemJJE · Traditional | 11/07/1983SE |
| K832716 | Encore Chemistry AnalyzerJJG · Traditional | 10/04/1983SE |
| K830641 | Encore Chemistry AnalyzerJJG · Traditional | 04/05/1983SE |
| K821956 | Haem-C Plus Blood Reference ControlsJCN · Traditional | 07/30/1982SE |
Questions and answers
When was Centrifichem Alt/Agpt Optimized Reagent cleared by the FDA?
Centrifichem Alt/Agpt Optimized Reagent (K811694) received a 510(k) decision of Substantially Equivalent on July 1, 1981, 16 days after the submission was received.
What is the product code of K811694?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.