Gamma-Glutamyl Transferase Determination
FDA 510(k) K905649 · Biochemical Trade, Inc.
510(k) numberK905649
Submission
- Device name
- Gamma-Glutamyl Transferase Determination
- Applicant
- Biochemical Trade, Inc.
Miami, FL, US - Received
- December 18, 1990
- Decision date
- January 30, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K942958 | Creatine Kinase MB Determination (UV)JHW · Traditional | 11/21/1994SE |
| K910635 | Total Bilirubin Reagent SetCIG · Traditional | 05/15/1991SE |
| K910296 | Phosphorus (Inorganic) Test SystemCEO · Traditional | 02/27/1991SE |
| K905776 | Albumin Reagent SetCJW · Traditional | 02/26/1991SE |
| K905790 | Total Protein Reagent SetCEK · Traditional | 02/21/1991SE |
| K905650 | Kinetic Alkaline Phosphatase DeterminationCJE · Traditional | 02/13/1991SE |
| K905619 | Creatinine (Rate) Reagent SetCGX · Traditional | 02/13/1991SE |
| K905651 | Kinetic Amylase DeterminationJFJ · Traditional | 01/31/1991SE |
| K905588 | Creatine Kinase UV Reagent SetJHW · Traditional | 01/17/1991SE |
| K871547 | Ultra-Violet Bun Reagent Kit (Rate)CDQ · Traditional | 06/22/1987SE |
Questions and answers
When was Gamma-Glutamyl Transferase Determination cleared by the FDA?
Gamma-Glutamyl Transferase Determination (K905649) received a 510(k) decision of Substantially Equivalent on January 30, 1991, 43 days after the submission was received.
What is the product code of K905649?
The FDA product code is JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.