Cleared Traditional

PARAMAX AMYLASE REAGENT

K873520 · Baxter Healthcare Corp · Chemistry
Nov 1987
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K873520 is an FDA 510(k) clearance for the PARAMAX AMYLASE REAGENT, a Amyloclastic, Amylase (Class II — Special Controls, product code CJA), submitted by Baxter Healthcare Corp (Santa Ana, US). The FDA issued a Cleared decision on November 23, 1987, 83 days after receiving the submission on September 1, 1987. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K873520 FDA.gov
FDA Decision Cleared SESE
Date Received September 01, 1987
Decision Date November 23, 1987
Days to Decision 83 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CJA — Amyloclastic, Amylase
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1070

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