Dma Gamma Glutamyltransferase (GGT) Procedure
FDA 510(k) K961919 · Data Medical Associates, Inc.
510(k) numberK961919
Submission
- Device name
- Dma Gamma Glutamyltransferase (GGT) Procedure
- Applicant
- Data Medical Associates, Inc.
Arlington, TX, US - Received
- May 17, 1996
- Decision date
- July 1, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
| 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 |
| K871979 | Gamma Glutamyltransferase ReagentJPZ · Traditional | Intersect Systems, Inc. | 06/11/1987SE |
More from Intersect Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993098 | Hdl-C/Ldl-C Calibrator, Model 1913-003JIX · Traditional | 10/08/1999SE |
| K971113 | Dma Triglycerides ProceduresCDT · Traditional | 05/29/1997SE |
| K955796 | Iron Calibrator & Calibration Verification SetJJX · Traditional | 02/29/1996SE |
| K955302 | Serum Bicarbonate/Carbon DioxideKHS · Traditional | 02/29/1996SE |
| K955300 | Total Bilirubin ProcedureCIG · Traditional | 12/20/1995SE |
| K952437 | Dma Glucose Hexokinase U.V. ProcedureCFR · Traditional | 10/03/1995SE |
| K946161 | Dma Total Cholesterol ProcedureCHH · Traditional | 08/23/1995SE |
| K946354 | Dma Unsaturated Iron Binding Capacity ProcedureJMO · Traditional | 05/08/1995SE |
| K946355 | Dma Albumin ProcedureCIX · Traditional | 03/01/1995SE |
| K944255 | Dma Calcium Plus ProcedureCJY · Traditional | 12/06/1994SE |
Questions and answers
When was Dma Gamma Glutamyltransferase (GGT) Procedure cleared by the FDA?
Dma Gamma Glutamyltransferase (GGT) Procedure (K961919) received a 510(k) decision of Substantially Equivalent on July 1, 1996, 45 days after the submission was received.
What is the product code of K961919?
The FDA product code is JPZ – Colorimetric Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.