PERKIN ELMER MODEL 91 AMYLASE REAGENT— 510(k) K801096

Name: FDA 510(k) clearance K801096
Creator: U.S. Food and Drug Administration
Published: 1980-06-09

Substantially Equivalent

Stat Engineering

FDA 510(k) clearance K801096 for PERKIN ELMER MODEL 91 AMYLASE REAGENT, Substantially Equivalent on 1980-06-09. Applicant: Stat Engineering. Device class: 2.

Clearance details

Applicant: Stat Engineering
Product code: Code KHM
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1980-05-09
Decision date: 1980-06-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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K812699 — AMYLASE1981-10-06
K812447 — AMYLASE REAGENT KIT1981-09-09
K790797 — AMYLASE REAGENT SET1979-07-17
K770400 — REAGENT, AMYLASE LIPASE1977-04-26

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