Altlts Alanine Amino Transferase Alt
FDA 510(k) K883205 · Electro-Nucleonics, Inc.
510(k) numberK883205
Submission
- Device name
- Altlts Alanine Amino Transferase Alt
- Applicant
- Electro-Nucleonics, Inc.
Columbia, MD, US - Received
- July 28, 1988
- Decision date
- September 9, 1988
- 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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| 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.
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|---|---|---|
| K893718 | Deltatest (R) Lipase IICET · Traditional | 09/28/1989SE |
| K883670 | Serological Test Kit for Igg Anti. Epstein-Barr ViGNP · Traditional | 04/28/1989SE |
| K883427 | Virgo(R) Vzv-Igg ElisaGQX · Traditional | 03/10/1989SE |
| K883282 | Virgo HSV-1 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883281 | Virgo HSV-2 Igg ElisaGQO · Traditional | 03/10/1989SE |
| K883102 | Virgo (R) Cmv-Igg ElisaGQI · Traditional | 02/08/1989SE |
| K884784 | Virgo(R) Microwell Alt AssayCKD · Traditional | 12/29/1988SE |
| K883206 | Lactate Dehydrogenase LDHCFJ · Traditional | 09/09/1988SE |
Questions and answers
When was Altlts Alanine Amino Transferase Alt cleared by the FDA?
Altlts Alanine Amino Transferase Alt (K883205) received a 510(k) decision of Substantially Equivalent on September 9, 1988, 43 days after the submission was received.
What is the product code of K883205?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.