Ultra Zyme Plus GPT, #64956, 65035 & 36
FDA 510(k) K812591 · Harleco
510(k) numberK812591
Submission
- Device name
- Ultra Zyme Plus GPT, #64956, 65035 & 36
- Applicant
- Harleco
Mchenry, IL, US - Received
- September 11, 1981
- Decision date
- September 24, 1981
- 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 |
| 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 |
|---|---|---|
| K820233 | Ultrazyme Plus Gamma GT(65055-65056)JQB · Traditional | 02/12/1982SE |
| K813427 | Ultrachem Gluc-DhLFR · Traditional | 12/31/1981SE |
| K813044 | Ultrachem Alb, Item #64970CIX · Traditional | 11/10/1981SE |
| K813043 | Ultrachem Crea Item #64972CGX · Traditional | 11/10/1981SE |
| K813042 | Ultrachem Gluc-Dh Set, Item #65048LFR · Traditional | 11/10/1981SE |
| K813041 | Ultrazyme-Gt, Item #64959 & 65032JQB · Traditional | 11/10/1981SE |
| K813040 | Ultrachem Ca, Item #64975CJY · Traditional | 11/10/1981SE |
| K813039 | Ultrachem E-Chol, Item #65025CHH · Traditional | 11/10/1981SE |
| K813038 | Ultrachem TP, Item #64974CEK · Traditional | 11/10/1981SE |
| K812594 | Ultra Zyme Plus Amyl #64982 & 65031CIJ · Traditional | 10/02/1981SE |
Questions and answers
When was Ultra Zyme Plus GPT, #64956, 65035 & 36 cleared by the FDA?
Ultra Zyme Plus GPT, #64956, 65035 & 36 (K812591) received a 510(k) decision of Substantially Equivalent on September 24, 1981, 13 days after the submission was received.
What is the product code of K812591?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.