Gemeni GPT (Alt) Assay
FDA 510(k) K761269 · Electro-Nucleonics Laboratories, Inc.
510(k) numberK761269
Submission
- Device name
- Gemeni GPT (Alt) Assay
- Applicant
- Electro-Nucleonics Laboratories, Inc.
Mchenry, IL, US - Received
- December 16, 1976
- Decision date
- December 29, 1976
- 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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|---|---|---|---|
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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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| K873358 | Gemeni Uric Acid U.V.CDO · Traditional | 09/11/1987SE |
| K873088 | Virgo(Tm) Rubella Igg ElisaLFX · Traditional | 09/09/1987SE |
| K871905 | Toxoplasma Gondii Igg ElisaLGD · Traditional | 07/30/1987SE |
| K870928 | Cholesterol (Total) Analysis ProductsCHH · Traditional | 04/22/1987SE |
| K863874 | Lipase Hydrolysis/Glycerol Kinase, TriglyceridesCDT · Traditional | 11/13/1986SE |
| K862640 | Amylase LTSCJA · Traditional | 09/09/1986SE |
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Questions and answers
When was Gemeni GPT (Alt) Assay cleared by the FDA?
Gemeni GPT (Alt) Assay (K761269) received a 510(k) decision of Substantially Equivalent on December 29, 1976, 13 days after the submission was received.
What is the product code of K761269?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.