SGPT (Alt) Reagent Set (Colorimetric)
FDA 510(k) K860485 · Sterling Diagnostics, Inc.
510(k) numberK860485
Submission
- Device name
- SGPT (Alt) Reagent Set (Colorimetric)
- Applicant
- Sterling Diagnostics, Inc.
Sterling Heights, MI, US - Received
- February 10, 1986
- Decision date
- April 3, 1986
- 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 |
| 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 |
| K820491 | SGPT Reagent SetCKD · Traditional | Anco Medical Reagents & Assoc. | 03/11/1982SE |
More from Anco Medical Reagents & Assoc.
| 510(k) | Device | Decision |
|---|---|---|
| K921412 | Microprotein Reagent SetCEK · Traditional | 01/21/1993SE |
| K914609 | Triglycerides Reagent SetCDT · Traditional | 11/07/1991SE |
| K914039 | Sodium Reagent SetCEI · Traditional | 10/31/1991SE |
| K914040 | Phospholipid Reagent SetJNT · Traditional | 10/30/1991SE |
| K862255 | Lactate Dehydrogenase (LDH) Reagent Set (UV Rate)CFJ · Traditional | 07/29/1986SE |
| K861962 | Vanilmandelic Acid (Vma) Reagent SetCDF · Traditional | 07/07/1986SE |
| K862256 | Alkaline Phosphatase (PNPP Rate) Reagent SetCJE · Traditional | 07/01/1986SE |
| K862210 | Urea Nitrogen (GLDH) Reagent Set (UV)CDQ · Traditional | 07/01/1986SE |
| K862209 | Alt (SGPT) Reagent Set (UV Rate)CKA · Traditional | 06/25/1986SE |
| K861855 | Hydroxybutyrate Dehydrogenase (HBD) Reagent SetJKF · Traditional | 06/16/1986SE |
Questions and answers
When was SGPT (Alt) Reagent Set (Colorimetric) cleared by the FDA?
SGPT (Alt) Reagent Set (Colorimetric) (K860485) received a 510(k) decision of Substantially Equivalent on April 3, 1986, 52 days after the submission was received.
What is the product code of K860485?
The FDA product code is CKD – Hydrazone Colorimetry, Alt/Sgpt, a Class I (low risk) device regulated under 21 CFR 862.1030.