Wako(Tm) Autokit Gamma-Gt
FDA 510(k) K895984 · Wako Chemicals USA, Inc.
510(k) numberK895984
Submission
- Device name
- Wako(Tm) Autokit Gamma-Gt
- Applicant
- Wako Chemicals USA, Inc.
Richmond, VA, US - Received
- October 13, 1989
- Decision date
- November 8, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JPZ – Colorimetric 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 JPZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K020486 | Careside GGTJPZ · Traditional | Careside, Inc. | 07/01/2002SE |
| K961919 | Dma Gamma Glutamyltransferase (GGT) ProcedureJPZ · Traditional | Data Medical Associates, Inc. | 07/01/1996SE |
| K923509 | Gamma-GtJPZ · Traditional | Randox Laboratories, Ltd. | 12/03/1992SE |
| K923091 | King Diagnostics Gamma GT ReagentJPZ · Traditional | King Diagnostics, Inc. | 09/09/1992SE |
| K905618 | GGT ReagentJPZ · Traditional | Amresco, Inc. | 02/26/1991SE |
| K903304 | Roche Cobas Ready GGT ReagentJPZ · Traditional | Roche Diagnostic Systems, Inc. | 10/12/1990SE |
| K901090 | Elitech Gamma GT Test KitJPZ · Traditional | Elite Technology, Inc. | 03/29/1990SE |
| K881239 | Gamma Glutamyl Transferase Reagent SetJPZ · Traditional | Tech-Neal Scientific, Inc. | 05/31/1988SE |
| K874903 | Multichem(R) Y -Glutamyltransferase (Y -Gt)JPZ · Traditional | Simmler, Inc. | 02/11/1988SE |
| K871979 | Gamma Glutamyltransferase ReagentJPZ · Traditional | Intersect Systems, Inc. | 06/11/1987SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K100464 | Utaswako I30 (Includes Accessories), Utaswako AFP-L3, Calibrator Set, Control L, Control…NSF · Traditional | 02/23/2011SE |
| K080125 | Apolowako T-Cho, Hdl-C, TG and Analyzer, Models 993-23501, 999-23601, 995-23701 and…LBS · Traditional | 07/18/2008SE |
| K080123 | Apolowako HBA1C, Glucose and Analyzer, Models 993-24601, 991-24401 and 993-25201CFR · Traditional | 07/17/2008SE |
| K061775 | Wako L-Type Creatinine-M Test, and Wako Creatinine CalibratorJFY · Traditional | 02/23/2007SE |
| K062368 | Wako Lba DCP Test System, Model 993-05301; DCP Control Set, Model 995-0551; DCP…OAU · Traditional | 01/31/2007SE |
| K053132 | Wako Direct Bilirubin V, Models 996-23591, 412-22901, 992-23691, 998-23791JFM · Traditional | 12/30/2005SE |
| K053131 | Wako Total Bilirubin V, Models 410-22701, 998-23291, 416-22801, 990-23191JFM · Traditional | 12/30/2005SE |
| K042551 | Multi-Chem Calibrator aJIX · Traditional | 11/16/2004SE |
| K042550 | Multi-Lipid CalibratorJIX · Traditional | 11/08/2004SE |
| K042549 | Multi Chem Cal BJIX · Traditional | 11/08/2004SE |
Questions and answers
When was Wako(Tm) Autokit Gamma-Gt cleared by the FDA?
Wako(Tm) Autokit Gamma-Gt (K895984) received a 510(k) decision of Substantially Equivalent on November 8, 1989, 26 days after the submission was received.
What is the product code of K895984?
The FDA product code is JPZ – Colorimetric Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.