Gamma-Glutamyl Transpeptidase
FDA 510(k) K964916 · Derma Media Lab., Inc.
510(k) numberK964916
Submission
- Device name
- Gamma-Glutamyl Transpeptidase
- Applicant
- Derma Media Lab., Inc.
Santa Fe Springs, CA, US - Received
- December 9, 1996
- Decision date
- January 10, 1997
- 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 |
| 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 |
| K941315 | Stanbio Y-Gt (Liquicolor) Test SetJQB · Traditional | Stanbio Laboratory | 07/14/1994SE |
More from Stanbio Laboratory
| 510(k) | Device | Decision |
|---|---|---|
| K971309 | UreaCDQ · Traditional | 08/01/1997SE |
| K970664 | Glucose ReagentCFR · Traditional | 08/01/1997SE |
| K971072 | Cholesterol ReagentCHH · Traditional | 06/20/1997SE |
| K971005 | TriglyceridesJGY · Traditional | 04/21/1997SE |
| K970867 | Uric Acid ReagentKNK · Traditional | 04/21/1997SE |
| K964915 | MagnesiumJGJ · Traditional | 03/26/1997SE |
| K964913 | Iron ReagentJIY · Traditional | 02/20/1997SE |
| K965134 | Alt/SgptCKA · Traditional | 02/18/1997SE |
| K964914 | Alkaline PhosphataseCJE · Traditional | 02/04/1997SE |
| K965126 | Ast/SgotCIT · Traditional | 01/17/1997SE |
Questions and answers
When was Gamma-Glutamyl Transpeptidase cleared by the FDA?
Gamma-Glutamyl Transpeptidase (K964916) received a 510(k) decision of Substantially Equivalent on January 10, 1997, 32 days after the submission was received.
What is the product code of K964916?
The FDA product code is JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.