AMYLASE REAGENT SET (MODIFIED CARAWAY)— 510(k) K860530

Name: FDA 510(k) clearance K860530
Creator: U.S. Food and Drug Administration
Published: 1986-02-28

Substantially Equivalent

Sterling Diagnostics, Inc.

FDA 510(k) clearance K860530 for AMYLASE REAGENT SET (MODIFIED CARAWAY), Substantially Equivalent on 1986-02-28. Applicant: Sterling Diagnostics, Inc.. Device class: 2.

Clearance details

Applicant: Sterling Diagnostics, Inc.
Product code: Code CJA
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1986-02-12
Decision date: 1986-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sterling Heights, MI, US

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K862640 — AMYLASE LTS1986-09-09

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K914040 — PHOSPHOLIPID REAGENT SET1991-10-30
K862255 — LACTATE DEHYDROGENASE (LDH) REAGENT SET (UV RATE)1986-07-29

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