Gamma Gultamyl Transferase Test
FDA 510(k) K922947 · Em Diagnostic Systems, Inc.
510(k) numberK922947
Submission
- Device name
- Gamma Gultamyl Transferase Test
- Applicant
- Em Diagnostic Systems, Inc.
Gibbstown, NJ, US - Received
- June 18, 1992
- Decision date
- September 28, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- JQB – Kinetic 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 JQB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K974000 | Y-Glutamyltransferase-Sl Assay , Cataloge Number 324-10, 324-30JQB · Traditional | Diagnostic Chemicals , Ltd. | 11/04/1997SE |
| K973157 | Liquid GGT (Gamma Glutamyl Transferase) Reagent SetJQB · Traditional | Pointe Scientific, Inc., | 10/10/1997SE |
| K971466 | Synchron CX Systems Gamma-Glutamyl Transferase Reagent (GGT)JQB · Traditional | Carolina Liquid Chemistries Corp. | 05/06/1997SE |
| K964457 | Roche Cobas Ibtegra Reagent CassettesJQB · Traditional | Roche Diagnostic Systems, Inc. | 01/13/1997SE |
| K964916 | Gamma-Glutamyl TranspeptidaseJQB · Traditional | Derma Media Lab., Inc. | 01/10/1997SE |
| K955770 | Gamma Glutamyl Transferase Test SystemJQB · Traditional | Abaxis, Inc. | 09/09/1996SE |
| K945800 | Y-Glutamyltransferase Assay, Catalogue Number 308-05JQB · Traditional | Diagnostic Chemicals , Ltd. | 06/09/1995SE |
| K946192 | Hichem Y-Gt Reagent KitJQB · Traditional | Hichem Diagnostics | 05/02/1995SE |
| K942962 | GGT QvetJQB · Traditional | Prisma Systems | 12/07/1994SE |
| K935984 | Glutamyl-Transferase, Procedure No. 419JQB · Traditional | Sigma Diagnostics, Inc. | 07/20/1994SE |
More from Sigma Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K935181 | Aspartate Aminotransferase (Ast) TestCIT · Traditional | 01/27/1994SE |
| K935180 | Alanine Aminotransferase (Alt) TestCKA · Traditional | 01/13/1994SE |
| K935179 | Emds Albumin (Alb) TestCIX · Traditional | 12/17/1993SE |
| K935178 | Emds Phosphorous (Phos) TestCEO · Traditional | 12/17/1993SE |
| K935177 | Gamma-Glutamyl Transferase (GGT) TestJQB · Traditional | 12/16/1993SE |
| K935176 | Iron TestJIY · Traditional | 12/16/1993SE |
| K935175 | Lactate Dehydrogenase (LD)CFJ · Traditional | 12/16/1993SE |
| K935174 | Total Protein Test (Tpro)CEK · Traditional | 12/16/1993SE |
| K935136 | Cholesterol (Chol) Test Item No. 65410CHH · Traditional | 12/16/1993SE |
| K935183 | Emds Magnesium (MG) TestJGJ · Traditional | 12/09/1993SE |
Questions and answers
When was Gamma Gultamyl Transferase Test cleared by the FDA?
Gamma Gultamyl Transferase Test (K922947) received a 510(k) decision of Substantially Equivalent on September 28, 1992, 102 days after the submission was received.
What is the product code of K922947?
The FDA product code is JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.