Solarcare Alanine Aminotransferase Micro-Plate Assay
FDA 510(k) K941497 · Solarcare, Inc.
510(k) numberK941497
Submission
- Device name
- Solarcare Alanine Aminotransferase Micro-Plate Assay
- Applicant
- Solarcare, Inc.
Bethlehem, PA, US - Received
- March 28, 1994
- Decision date
- May 24, 1994
- 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 Solarcare Alanine Aminotransferase Micro-Plate Assay cleared by the FDA?
Solarcare Alanine Aminotransferase Micro-Plate Assay (K941497) received a 510(k) decision of Substantially Equivalent on May 24, 1994, 57 days after the submission was received.
What is the product code of K941497?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.