AMYLASE REAGENT— 510(k) K864356

Substantially Equivalent

Trace Scientific , Ltd.

FDA 510(k) clearance K864356 for AMYLASE REAGENT, Substantially Equivalent on 1987-01-21. Applicant: Trace Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Trace Scientific , Ltd.
Product code: Code CIJ
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1986-11-03
Decision date: 1987-01-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Clayton, Vic 3168, AU

Download summary PDF View on FDA.gov ↗

Recent devices under product code CIJ

K023396 — AMYLASE EPS-G7 (LIQUID) REAGENT SET, (HITACHI ANALYZERS)2002-12-23
K991817 — ADDITIONAL IMS ASSAYS FOR THE BAYER ADVIA IMS SYSTEM1999-07-22
K980013 — AMYLASE1998-02-04
K953211 — AMYLASE (ETHYLIDENE PNGPG7) KIT1996-06-21
K951494 — AMYLASE TEST ITEM 97381/94 (R1, 97382/94 (R2-SR)1995-12-11

More clearances from Trace Scientific , Ltd.

K982121 — ENZYMATIC MITOCHONDRIAL ANTIBODY (M2) REAGENT1998-09-17
K981123 — UREA1998-04-24
K962890 — CHOLESTEROL-INCORPORATING DYNAMIC STAB TECH (DST)1996-09-27
K961114 — AST INCORPORATING DST1996-05-23
K961123 — ALT INCORPORATING DST1996-04-25

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