Cleared Traditional

K911640 - OLYMPUS PK TP(TM) SYSTEM, MODIFICATION (FDA 510(k) Clearance)

K911640 · Olympus Corp. · Microbiology device

Jul 1991

Decision

107d

Days

Class 2

Risk

K911640 is an FDA 510(k) clearance for the OLYMPUS PK TP(TM) SYSTEM, MODIFICATION. This device is classified as a Antigens, Ha, Treponema Pallidum (Class II - Special Controls, product code GMT).

Submitted by Olympus Corp. (Lake Success, US). The FDA issued a Cleared decision on July 24, 1991, 107 days after receiving the submission on April 8, 1991.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3830.

Submission Details

510(k) Number	K911640 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 08, 1991
Decision Date	July 24, 1991
Days to Decision	107 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—