Cleared Traditional

CHLAMYDIATROL AG

K972129 · Blackhawk Biosystems, Inc. · Microbiology
Aug 1997
Decision
67d
Days
Class 1
Risk

About This 510(k) Submission

K972129 is an FDA 510(k) clearance for the CHLAMYDIATROL AG, a Kit, Direct Antigen, Positive Control (Class I — General Controls, product code MJZ), submitted by Blackhawk Biosystems, Inc. (San Ramon, US). The FDA issued a Cleared decision on August 12, 1997, 67 days after receiving the submission on June 6, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K972129 FDA.gov
FDA Decision Cleared SESE
Date Received June 06, 1997
Decision Date August 12, 1997
Days to Decision 67 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code MJZ — Kit, Direct Antigen, Positive Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1660