Y-Glutamyltransferase Assay, Catalogue Number 308-05
FDA 510(k) K945800 · Diagnostic Chemicals , Ltd.
510(k) numberK945800
Submission
- Device name
- Y-Glutamyltransferase Assay, Catalogue Number 308-05
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottestown,Pei,Canada, CA - Received
- November 28, 1994
- Decision date
- June 9, 1995
- 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 |
| 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 |
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Questions and answers
When was Y-Glutamyltransferase Assay, Catalogue Number 308-05 cleared by the FDA?
Y-Glutamyltransferase Assay, Catalogue Number 308-05 (K945800) received a 510(k) decision of Substantially Equivalent on June 9, 1995, 193 days after the submission was received.
What is the product code of K945800?
The FDA product code is JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.