GGT Reagents, 7738, 7739, 7538, 7438 & 7138
FDA 510(k) K905096 · Amresco, Inc.
510(k) numberK905096
Submission
- Device name
- GGT Reagents, 7738, 7739, 7538, 7438 & 7138
- Applicant
- Amresco, Inc.
Solon, OH, US - Received
- November 13, 1990
- Decision date
- November 28, 1990
- 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 |
|---|---|---|
| K905618 | GGT ReagentJPZ · Traditional | 02/26/1991SE |
| K904468 | Direct Bilirubin Reagent, 7776/7777/7576/7476/7176CIG · Traditional | 01/17/1991SE |
| K905684 | Alkaline PhosphataseCJE · Traditional | 12/28/1990SE |
| K905544 | Magnesium ReagentJGJ · Traditional | 12/27/1990SE |
| K905284 | Hdl-Cholesterol Precipitant 7773/7573/7473/7173LBR · Traditional | 12/11/1990SE |
| K904004 | Amrescocreat Kinase Reagent 7716/17,7516,7416,7116CGS · Traditional | 12/11/1990SE |
| K904381 | Diazo Colorimentry Direct BilirubinCIG · Traditional | 10/12/1990SE |
| K903775 | Creatine PhosphokinaseCGS · Traditional | 10/04/1990SE |
| K903829 | Ast ReagentCIT · Traditional | 09/25/1990SE |
| K904007 | Bicarbonate Reagents Amresco Product #4326020KHS · Traditional | 09/13/1990SE |
Questions and answers
When was GGT Reagents, 7738, 7739, 7538, 7438 & 7138 cleared by the FDA?
GGT Reagents, 7738, 7739, 7538, 7438 & 7138 (K905096) received a 510(k) decision of Substantially Equivalent on November 28, 1990, 15 days after the submission was received.
What is the product code of K905096?
The FDA product code is JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.