Cleared Traditional

K922765 - BIOSTARS STREP A OIA -- MODIFICATION
(FDA 510(k) Clearance)

K922765 · Biosearch Medical Products, Inc. · Microbiology

Aug 1992

Decision

79d

Days

Class 1

Risk

K922765 is an FDA 510(k) clearance for the BIOSTARS STREP A OIA -- MODIFICATION. This device is classified as a Antigens, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTY).

Submitted by Biosearch Medical Products, Inc. (Boulder, US). The FDA issued a Cleared decision on August 20, 1992, 79 days after receiving the submission on June 2, 1992.

This device falls under the Microbiology FDA review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K922765 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 02, 1992
Decision Date	August 20, 1992
Days to Decision	79 days
Submission Type	Traditional
Review Panel	Microbiology (MI)
Summary	Statement