Cleared Traditional

AMYLASE REAGENT SET (MODIFIED CARAWAY)

K860530 · Sterling Diagnostics, Inc. · Chemistry
Feb 1986
Decision
16d
Days
Class 2
Risk

About This 510(k) Submission

K860530 is an FDA 510(k) clearance for the AMYLASE REAGENT SET (MODIFIED CARAWAY), a Amyloclastic, Amylase (Class II — Special Controls, product code CJA), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on February 28, 1986, 16 days after receiving the submission on February 12, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1070.

Submission Details

510(k) Number K860530 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 1986
Decision Date February 28, 1986
Days to Decision 16 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