Assay for Gamma Glutamyltransferase
FDA 510(k) K760346 · Princeton Biomedix
510(k) numberK760346
Submission
- Device name
- Assay for Gamma Glutamyltransferase
- Applicant
- Princeton Biomedix
Mchenry, IL, US - Received
- August 2, 1976
- Decision date
- October 27, 1976
- 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 |
|---|---|---|
| K942052 | Lifesign Mi MyoglobinDDR · Traditional | 02/07/1995SE |
| K925355 | Biosign(Tm_ Rubella - Rubella Antibody TestLFX · Traditional | 07/12/1994SE |
| K930185 | Ovusign Lh/Conception Plus/Ovudate LH One-StepCEP · Traditional | 03/04/1993SE |
| K925183 | Biosign(Tm) Mono-Infect Mono Hetero Antibody TestKTN · Traditional | 02/23/1993SE |
| K926308 | Lifesign HCG - One Step Home Pregnancy TestLCX · Traditional | 01/26/1993SE |
| K901011 | Biosign Hcg-One Step Pregnancy TestJHI · Traditional | 05/04/1990SE |
| K894750 | Biostix I. HCG - One Step Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K894705 | Biospot Hcg-Rapid Pregnancy TestJHI · Traditional | 10/18/1989SE |
| K892654 | Biostix (Tm)Hcg--Simple Pregnancy TestDHA · Traditional | 06/19/1989SE |
| K761315 | Alkaline Phosphatase (Alp)/PnppCJE · Traditional | 02/24/1977SE |
Questions and answers
When was Assay for Gamma Glutamyltransferase cleared by the FDA?
Assay for Gamma Glutamyltransferase (K760346) received a 510(k) decision of Substantially Equivalent on October 27, 1976, 86 days after the submission was received.
What is the product code of K760346?
The FDA product code is JPZ – Colorimetric Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.