Alt(Optimized) Reagent
FDA 510(k) K854502 · Sigma Diagnostics, Inc.
510(k) numberK854502
Submission
- Device name
- Alt(Optimized) Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- November 12, 1985
- Decision date
- November 25, 1985
- 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
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| 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 |
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|---|---|---|
| K021162 | Amax Density Coagulation Analyzer, Amax Denstiny Coagulation Analyzer-Eu, Amax Destiny…JPA · Traditional | 08/30/2002SE |
| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
| K013549 | Sigma Diagnostics Auto D-Dimer Calibrator, Model A7971DAP · Traditional | 12/26/2001SE |
| K013545 | Sigma Diagnostics Auto D-Dimer Control, Level 3, Model A8221DAP · Traditional | 11/15/2001SE |
| K013544 | Sigma Diagnostics Auto D-Dimer Control, Level 2, Model A8096DAP · Traditional | 11/15/2001SE |
| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
| K010652 | Sigma Diagnostics Sigma-Cal, Model S2936JIX · Traditional | 03/30/2001SE |
| K010158 | Thrombomax-Hs with Calcium, Model T6540GGO · Traditional | 03/22/2001SE |
| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
| K003329 | Sigma Dianostics Auto D-Dimer Control Level 2, Model A5217GGC · Traditional | 03/01/2001SE |
Questions and answers
When was Alt(Optimized) Reagent cleared by the FDA?
Alt(Optimized) Reagent (K854502) received a 510(k) decision of Substantially Equivalent on November 25, 1985, 13 days after the submission was received.
What is the product code of K854502?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.