Gamma Glutamyl Transpeptidase (Kinectic)Reagentset
FDA 510(k) K855186 · Technostics Intl.
510(k) numberK855186
Submission
- Device name
- Gamma Glutamyl Transpeptidase (Kinectic)Reagentset
- Applicant
- Technostics Intl.
Washington, MI, US - Received
- December 26, 1985
- Decision date
- January 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPZ – Colorimetric Method, Gamma-Glutamyl Transpeptidase
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.1360
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020486 | Careside GGTJPZ · Traditional | Careside, Inc. | 07/01/2002SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | Data Medical Associates, Inc. | 07/01/1996SE |
| K923509 | Gamma-GtJPZ · Traditional | Randox Laboratories, Ltd. | 12/03/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | King Diagnostics, Inc. | 09/09/1992SE |
| K905618 | GGT ReagentJPZ · Traditional | Amresco, Inc. | 02/26/1991SE |
| K903304 | Roche Cobas Ready GGT ReagentJPZ · Traditional | Roche Diagnostic Systems, Inc. | 10/12/1990SE |
| K901090 | Elitech Gamma GT Test KitJPZ · Traditional | Elite Technology, Inc. | 03/29/1990SE |
| K895984 | Wako(Tm) Autokit Gamma-GtJPZ · Traditional | Wako Chemicals USA, Inc. | 11/08/1989SE |
| K881239 | Gamma Glutamyl Transferase Reagent SetJPZ · Traditional | Tech-Neal Scientific, Inc. | 05/31/1988SE |
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | Simmler, Inc. | 02/11/1988SE |
More from Simmler, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K855188 | CPK (UV) Reagent KitJHS · Traditional | 03/05/1986SE |
| K860111 | Uric Acid Reagent SetLFQ · Traditional | 02/19/1986SE |
| K855190 | Magnesium Reagent SetJGJ · Traditional | 02/18/1986SE |
| K860110 | Glutamic Pyruvic Transaminase, Gpt(Uv) Reagent SetCKA · Traditional | 02/11/1986SE |
| K860109 | Enzymatic Urea Nitrogen Reagent SetCDQ · Traditional | 02/06/1986SE |
| K860112 | Total Lipids Reagent SetCFD · Traditional | 01/24/1986SE |
| K855185 | Glucose Reagent SetCGE · Traditional | 01/22/1986SE |
| K855157 | Lactic Dehydrogenase (VV) Reagent SetCFJ · Traditional | 01/21/1986SE |
| K855195 | Direct & Total Bilirubin SetCIG · Traditional | 01/14/1986SE |
| K855194 | Glucose Oxidase Reagent SetCGA · Traditional | 01/14/1986SE |
Questions and answers
When was Gamma Glutamyl Transpeptidase (Kinectic)Reagentset cleared by the FDA?
Gamma Glutamyl Transpeptidase (Kinectic)Reagentset (K855186) received a 510(k) decision of Substantially Equivalent on January 14, 1986, 19 days after the submission was received.
What is the product code of K855186?
The FDA product code is JPZ – Colorimetric Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.