Reagent GPT, Enzyme
FDA 510(k) K770314 · Icn Pharmaceuticals, Inc.
510(k) numberK770314
Submission
- Device name
- Reagent GPT, Enzyme
- Applicant
- Icn Pharmaceuticals, Inc.
Orangeburg, NY, US - Received
- February 16, 1977
- Decision date
- March 30, 1977
- 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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| K120945 | Hitachi Clinical Analyzer S Test Reagent Cartridge Alt, Hitachi Clinical Analyzer S Test…CKA · Traditional | Hitachi Chemical Diagnostics, Inc. | 06/07/2013SE |
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| 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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| K951329 | Immuchem Gal-Mw EaJIA · Traditional | 11/09/1995SE |
| K914530 | Ican GT Drainage BagFRQ · Traditional | 12/18/1991SE |
| K914082 | Suan Flat Dissector SpongesGDY · Traditional | 11/27/1991SE |
| K914086 | Ican Cylindrical SpongesGDX · Traditional | 10/09/1991SE |
| K914083 | Ican K Dissector SpongesGDY · Traditional | 10/09/1991SE |
| K914081 | Ican Cotton Rayon BallsFRL · Traditional | 10/09/1991SE |
| K913446 | Ican Needle CountersMMK · Traditional | 09/13/1991SE |
| K904398 | Water Column Relief ValveCAF · Traditional | 07/09/1991SE |
| K770458 | Bilirubin Procedure, Tekpoint Tot & Dir.CIG · Traditional | 05/10/1977SE |
Questions and answers
When was Reagent GPT, Enzyme cleared by the FDA?
Reagent GPT, Enzyme (K770314) received a 510(k) decision of Substantially Equivalent on March 30, 1977, 42 days after the submission was received.
What is the product code of K770314?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.