Roche Cobas Ready GGT Reagent
FDA 510(k) K903304 · Roche Diagnostic Systems, Inc.
510(k) numberK903304
Submission
- Device name
- Roche Cobas Ready GGT Reagent
- Applicant
- Roche Diagnostic Systems, Inc.
Montclair, NJ, US - Received
- July 24, 1990
- Decision date
- October 12, 1990
- 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 |
| 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 |
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Questions and answers
When was Roche Cobas Ready GGT Reagent cleared by the FDA?
Roche Cobas Ready GGT Reagent (K903304) received a 510(k) decision of Substantially Equivalent on October 12, 1990, 80 days after the submission was received.
What is the product code of K903304?
The FDA product code is JPZ – Colorimetric Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.