Cleared Traditional

K862332 - ANAEROBE RAPID CHROMOGENIC ID PANEL
(FDA 510(k) Clearance)

K862332 · American Micro Scan · Microbiology

Aug 1986

Decision

69d

Days

Class 1

Risk

K862332 is an FDA 510(k) clearance for the ANAEROBE RAPID CHROMOGENIC ID PANEL. This device is classified as a Kit, Anaerobic Identification (Class I — General Controls, product code JSP).

Submitted by American Micro Scan (West Sacramento, US). The FDA issued a Cleared decision on August 27, 1986, 69 days after receiving the submission on June 19, 1986.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.2660.

Submission Details

510(k) Number	K862332 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1986
Decision Date	August 27, 1986
Days to Decision	69 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—