GGT Qvet

FDA 510(k) K942962 · Prisma Systems

Substantially Equivalent

510(k) numberK942962

Submission

Device name
GGT Qvet
Applicant
Prisma Systems
Rome, NY, US
Received
June 23, 1994
Decision date
December 7, 1994
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

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)DeviceApplicantDecision
K974000Y-Glutamyltransferase-Sl Assay , Cataloge Number 324-10, 324-30JQB · Traditional Diagnostic Chemicals , Ltd.11/04/1997SE
K973157Liquid GGT (Gamma Glutamyl Transferase) Reagent SetJQB · Traditional Pointe Scientific, Inc.,10/10/1997SE
K971466Synchron CX Systems Gamma-Glutamyl Transferase Reagent (GGT)JQB · Traditional Carolina Liquid Chemistries Corp.05/06/1997SE
K964457Roche Cobas Ibtegra Reagent CassettesJQB · Traditional Roche Diagnostic Systems, Inc.01/13/1997SE
K964916Gamma-Glutamyl TranspeptidaseJQB · Traditional Derma Media Lab., Inc.01/10/1997SE
K955770Gamma Glutamyl Transferase Test SystemJQB · Traditional Abaxis, Inc.09/09/1996SE
K945800Y-Glutamyltransferase Assay, Catalogue Number 308-05JQB · Traditional Diagnostic Chemicals , Ltd.06/09/1995SE
K946192Hichem Y-Gt Reagent KitJQB · Traditional Hichem Diagnostics05/02/1995SE
K935984Glutamyl-Transferase, Procedure No. 419JQB · Traditional Sigma Diagnostics, Inc.07/20/1994SE
K941315Stanbio Y-Gt (Liquicolor) Test SetJQB · Traditional Stanbio Laboratory07/14/1994SE

More from Stanbio Laboratory

510(k)DeviceDecision
K950177CK QvetCGS · Traditional 03/03/1995SE
K943027Cholesterol QvetCHH · Traditional 01/27/1995SE
K943042Bun QvetCDN · Traditional 12/29/1994SE
K943001Magnesium QvetJGJ · Traditional 12/29/1994SE
K942997Alkaline Phosphatase (Alkp) QvetCJE · Traditional 12/29/1994SE
K942964Lactate Dehydrogenase QvetCFJ · Traditional 12/29/1994SE
K942963Glucose QvetCFR · Traditional 12/29/1994SE
K944102Ast QvetCIT · Traditional 12/13/1994SE
K943000Albumin QvetCIX · Traditional 12/13/1994SE
K943026Potassium QvetCEJ · Traditional 12/09/1994SE

Questions and answers

When was GGT Qvet cleared by the FDA?

GGT Qvet (K942962) received a 510(k) decision of Substantially Equivalent on December 7, 1994, 167 days after the submission was received.

What is the product code of K942962?

The FDA product code is JQB – Kinetic Method, Gamma-Glutamyl Transpeptidase, a Class I (low risk) device regulated under 21 CFR 862.1360.