Cleared Traditional

K911266 - MODIFIED PK TP CONTROL
(FDA 510(k) Clearance)

K911266 · Olympus Corp. · Microbiology device

May 1991

Decision

53d

Days

Class 2

Risk

K911266 is an FDA 510(k) clearance for the MODIFIED PK TP CONTROL. 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 May 7, 1991, 53 days after receiving the submission on March 15, 1991.

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

Submission Details

510(k) Number	K911266 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 15, 1991
Decision Date	May 07, 1991
Days to Decision	53 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	—