CARESIDE GGT— 510(k) K020486

Substantially Equivalent

Careside, Inc.

FDA 510(k) clearance K020486 for CARESIDE GGT, Substantially Equivalent on 2002-07-01. Applicant: Careside, Inc.. Device class: 1.

Clearance details

Applicant: Careside, Inc.
Product code: Code JPZ
Device class: Class 1
Regulation: 21 CFR 862.1360
Advisory panel: Clinical Chemistry
Date received: 2002-02-13
Decision date: 2002-07-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Culver City, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code JPZ

K961919 — DMA GAMMA GLUTAMYLTRANSFERASE (GGT) PROCEDURE1996-07-01
K923509 — GAMMA-GT1992-12-03
K923091 — KING DIAGNOSTICS GAMMA GT REAGENT1992-09-09
K905618 — GGT REAGENT1991-02-26
K903304 — ROCHE COBAS READY GGT REAGENT1990-10-12

More clearances from Careside, Inc.

K020484 — CARESIDE LDH2002-07-03
K020487 — CARESIDE ALT2002-06-04
K020488 — CARESIDE TRGLYCERIDE2002-04-15
K002792 — CARESIDE CHOLINESTERASE2000-11-08
K001462 — CARESIDE HEMOGLOBIN2000-08-21

Data sourced from openFDA. This site is unofficial and independent of the FDA.