SGPT Reagent Set
FDA 510(k) K841060 · Medical Specialties, Inc.
510(k) numberK841060
Submission
- Device name
- SGPT Reagent Set
- Applicant
- Medical Specialties, Inc.
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- May 1, 1984
- 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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| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| 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 |
|---|---|---|
| K946201 | Stand, InfusionFOX · Traditional | 04/18/1995SE |
| K931947 | CheckpointJPK · Traditional | 06/18/1993SE |
| K926095 | Refractrol-SpJJX · Traditional | 01/26/1993SE |
| K924926 | Msi-HctGLK · Traditional | 01/07/1993SE |
| K896566 | Modified Fox Extra Gram Negative and PositiveJWY · Traditional | 02/09/1990SE |
| K883851 | Msi-Cal 8KRZ · Traditional | 11/22/1988SE |
| K883850 | Msi-Cal 16KRZ · Traditional | 11/22/1988SE |
| K883703 | Msi-Cal 7KRZ · Traditional | 11/22/1988SE |
| K880608 | Msi-PcGJP · Traditional | 03/21/1988SE |
| K880270 | Msi-Diff PlusJPK · Traditional | 03/01/1988SE |
Questions and answers
When was SGPT Reagent Set cleared by the FDA?
SGPT Reagent Set (K841060) received a 510(k) decision of Substantially Equivalent on May 1, 1984, 50 days after the submission was received.
What is the product code of K841060?
The FDA product code is CKA – Nadh Oxidation/Nad Reduction, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.