Cleared Traditional

MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129)

K895555 · Hichem Diagnostics · Chemistry
Dec 1989
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K895555 is an FDA 510(k) clearance for the MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129), a Amyloclastic, Amylase (Class II — Special Controls, product code CJA), submitted by Hichem Diagnostics (Brea, US). The FDA issued a Cleared decision on December 22, 1989, 107 days after receiving the submission on September 6, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K895555 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1989
Decision Date December 22, 1989
Days to Decision 107 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