SGPT Reagent Set
FDA 510(k) K820491 · Anco Medical Reagents & Assoc.
510(k) numberK820491
Submission
- Device name
- SGPT Reagent Set
- Applicant
- Anco Medical Reagents & Assoc.
Mchenry, IL, US - Received
- February 23, 1982
- Decision date
- March 11, 1982
- 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 |
| K844283 | SGPT Reagent SetCKD · Traditional | Livonia Diagnostics, Inc. | 11/27/1984SE |
| K841059 | SGPT Reagent SetCKD · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| K821207 | SGPT Reagent SetCKD · Traditional | Omega Medical Electronics | 07/14/1982SE |
More from Omega Medical Electronics
| 510(k) | Device | Decision |
|---|---|---|
| K842440 | Sickle Cell Stat A/S Heterozygous-ErythJPK · Traditional | 07/27/1984SE |
| K831871 | Sickle-Heme A/S Controls & A/A ControlGHM · Traditional | 07/28/1983SE |
| K821658 | Hemoglobin ReagentKHG · Traditional | 06/25/1982SE |
| K821526 | Acid Phosphatase Reagent SetCKE · Traditional | 06/10/1982SE |
| K821102 | Megnesium Reagent KitJGJ · Traditional | 05/05/1982SE |
| K820951 | Enzymatic Cholesterol KitCHH · Traditional | 04/26/1982SE |
| K820500 | Total Lipid Reagent SetCFD · Traditional | 03/11/1982SE |
| K820466 | Sgot Reagent SetCIQ · Traditional | 03/11/1982SE |
| K812837 | Alkaline Phosphatase Reagent SetCJL · Traditional | 01/29/1982SE |
| K813415 | Urea Nitrogen Reagent SetCDW · Traditional | 12/31/1981SE |
Questions and answers
When was SGPT Reagent Set cleared by the FDA?
SGPT Reagent Set (K820491) received a 510(k) decision of Substantially Equivalent on March 11, 1982, 16 days after the submission was received.
What is the product code of K820491?
The FDA product code is CKD – Hydrazone Colorimetry, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.