Hydrazone Colorimetry, Alt/Sgpt
The Hydrazone Colorimetry, ALT/SGPT test system (product code CKD) is an in-vitro diagnostic device used in clinical chemistry to measure alanine aminotransferase (ALT/SGPT) activity in serum using a hydrazone colorimetric method based on dinitrophenylhydrazone formation from the pyruvate product of the aminotransferase reaction. It is classified as FDA Class 1, the lowest risk tier, subject to general controls only and not requiring premarket notification. It falls under regulation 21 CFR 862.1030 in the Clinical Chemistry medical specialty.
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Basic Information
- Product Code
- CKD
- Device Class
- FDA class 1
- Regulation Number
- 862.1030
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | Sep 09, 1999 | Substantially Equivalent | Cholestech Corp. |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | May 16, 1995 | Substantially Equivalent | Ortho Diagnostic Systems, Inc. |
| K896237 | COBAS READY ALT REAGENT | Feb 16, 1990 | Substantially Equivalent | Roche Diagnostic Systems, Inc. |
| K884784 | VIRGO(R) MICROWELL ALT ASSAY | Dec 29, 1988 | Substantially Equivalent | Electro-Nucleonics, Inc. |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Oct 13, 1988 | Substantially Equivalent | Tech-Co, Inc. |
| K864082 | REFLOTRON(R) ALT (GPT) | Dec 04, 1986 | Substantially Equivalent | Boehringer Mannheim Corp. |
| K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) | Apr 03, 1986 | Substantially Equivalent | Sterling Diagnostics, Inc. |
| K844283 | SGPT REAGENT SET | Nov 27, 1984 | Substantially Equivalent | Livonia Diagnostics, Inc. |
| K841059 | SGPT REAGENT SET | May 01, 1984 | Substantially Equivalent | Medical Specialties, Inc. |
| K821207 | SGPT REAGENT SET | Jul 14, 1982 | Substantially Equivalent | Omega Medical Electronics |
| K820491 | SGPT REAGENT SET | Mar 11, 1982 | Substantially Equivalent | Anco Medical Reagents & Assoc. |
FEI Numbers
This FDA classification entry is associated with 6 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 6 registration numbers. Click on an entry to view related FDA registrations.