SGPT Reagent Set
FDA 510(k) K844283 · Livonia Diagnostics, Inc.
510(k) numberK844283
Submission
- Device name
- SGPT Reagent Set
- Applicant
- Livonia Diagnostics, Inc.
Livonia, MI, US - Received
- November 5, 1984
- Decision date
- November 27, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CKD – Hydrazone Colorimetry, Alt/Sgpt
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1030
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K991834 | Cholestech LDX Alanine Aminotransferase (Alt), Model 11-772CKD · Traditional | Cholestech Corp. | 09/09/1999SE |
| K941192 | Ortho Alt Microwell Test SystemCKD · Traditional | Ortho Diagnostic Systems, Inc. | 05/16/1995SE |
| K896237 | Cobas Ready Alt ReagentCKD · Traditional | Roche Diagnostic Systems, Inc. | 02/16/1990SE |
| K884784 | Virgo(R) Microwell Alt AssayCKD · Traditional | Electro-Nucleonics, Inc. | 12/29/1988SE |
| K883387 | Alanine Amino Transferase (Colorimetric Method)CKD · Traditional | Tech-Co, Inc. | 10/13/1988SE |
| K864082 | Reflotron(R) Alt (GPT)CKD · Traditional | Boehringer Mannheim Corp. | 12/04/1986SE |
| K860485 | SGPT (Alt) Reagent Set (Colorimetric)CKD · Traditional | Sterling Diagnostics, Inc. | 04/03/1986SE |
| K841059 | SGPT Reagent SetCKD · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821207 | SGPT Reagent SetCKD · Traditional | Omega Medical Electronics | 07/14/1982SE |
| K820491 | SGPT Reagent SetCKD · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K852161 | Serum Iron/Vibc Reagent SetJIY · Traditional | 06/10/1985SE |
| K844322 | Sgot Reagent SetCIQ · Traditional | 11/27/1984SE |
| K844237 | Alkaline Phosphatase Reagent SetCIO · Traditional | 11/20/1984SE |
| K844156 | Urea Nitrogen Reagent SetCDW · Traditional | 11/13/1984SE |
| K844182 | Inorganic Phosphorus Reagent SetCEO · Traditional | 11/09/1984SE |
| K843894 | HDL Precipatating Reagent SetLBR · Traditional | 11/02/1984SE |
| K844075 | Uric Acid Reagent SetLFQ · Traditional | 10/30/1984SE |
| K844024 | Creatinine Reagent SetCGX · Traditional | 10/30/1984SE |
| K843895 | Total Calcium Reagent SetCIC · Traditional | 10/30/1984SE |
| K843893 | Magnesium Reagent SetJGJ · Traditional | 10/30/1984SE |
Questions and answers
When was SGPT Reagent Set cleared by the FDA?
SGPT Reagent Set (K844283) received a 510(k) decision of Substantially Equivalent on November 27, 1984, 22 days after the submission was received.
What is the product code of K844283?
The FDA product code is CKD – Hydrazone Colorimetry, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.