Cobas Reagent for Alt (GPT)
FDA 510(k) K801119 · Roche Analytical Instruments, Inc.
510(k) numberK801119
Submission
- Device name
- Cobas Reagent for Alt (GPT)
- Applicant
- Roche Analytical Instruments, Inc.
Mchenry, IL, US - Received
- May 12, 1980
- Decision date
- June 9, 1980
- 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 |
|---|---|---|
| K801299 | Cobas Ck-Nac ReagentCGS · Traditional | 07/14/1980SE |
| K801298 | Cobas Reagent for Triglycerides & CobasCDT · Traditional | 07/08/1980SE |
| K801295 | Cobas Reagent for A-AmylaseJFJ · Traditional | 07/08/1980SE |
| K801297 | Cobas Reagent for Glucose RapidCFR · Traditional | 06/30/1980SE |
| K801296 | Cobas Reagent for CholesterolCHH · Traditional | 06/30/1980SE |
| K801243 | Cobas Reagents for Uric AcidCDO · Traditional | 06/26/1980SE |
| K801242 | Cobas Reagent for Alkaline PhosphataseCJE · Traditional | 06/20/1980SE |
| K801118 | Cobas Reagent for Ast (Sgot)CIT · Traditional | 06/20/1980SE |
| K801116 | Cobas Reagent for BunCDQ · Traditional | 06/17/1980SE |
| K801117 | Cobas Total Bilirubin Reagent & DiluentCIG · Traditional | 06/09/1980SE |
Questions and answers
When was Cobas Reagent for Alt (GPT) cleared by the FDA?
Cobas Reagent for Alt (GPT) (K801119) received a 510(k) decision of Substantially Equivalent on June 9, 1980, 28 days after the submission was received.
What is the product code of K801119?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.