Alt (GPT) - Alanine Aminotransferase
FDA 510(k) K923510 · Randox Laboratories, Ltd.
510(k) numberK923510
Submission
- Device name
- Alt (GPT) - Alanine Aminotransferase
- Applicant
- Randox Laboratories, Ltd.
Antrim, N. Ireland, IR - Received
- July 15, 1992
- Decision date
- November 16, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K971323 | Alt or SGPTCKA · Traditional | Carolina Liquid Chemistries Corp. | 04/21/1997SE |
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| K961123 | Alt Incorporating DSTCKA · Traditional | Trace Scientific , Ltd. | 04/25/1996SE |
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Questions and answers
When was Alt (GPT) - Alanine Aminotransferase cleared by the FDA?
Alt (GPT) - Alanine Aminotransferase (K923510) received a 510(k) decision of Substantially Equivalent on November 16, 1992, 124 days after the submission was received.
What is the product code of K923510?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.