ALPHA AMYLASE— 510(k) K863052

Substantially Equivalent

J. D. Assoc.

FDA 510(k) clearance K863052 for ALPHA AMYLASE, Substantially Equivalent on 1986-09-09. Applicant: J. D. Assoc.. Device class: 2.

Clearance details

Applicant: J. D. Assoc.
Product code: Code CJA
Device class: Class 2
Regulation: 21 CFR 862.1070
Advisory panel: Clinical Chemistry
Date received: 1986-08-12
Decision date: 1986-09-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Montclair, NJ, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CJA

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K884226 — AMYLASE REAGENT KIT FOR ASTRA SYSTEMS1988-12-09
K883059 — WAKO(TM) AUTOKIT AMYLASE1988-08-30
K873520 — PARAMAX AMYLASE REAGENT1987-11-23
K862640 — AMYLASE LTS1986-09-09

More clearances from J. D. Assoc.

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