Cleared Traditional

ABBOTT STREP A CONTROLS

K972182 · Abbott Diagnostics · Microbiology
Aug 1997
Decision
76d
Days
Class 1
Risk

About This 510(k) Submission

K972182 is an FDA 510(k) clearance for the ABBOTT STREP A CONTROLS, a Kit, Direct Antigen, Positive Control (Class I — General Controls, product code MJZ), submitted by Abbott Diagnostics (Abbott Park, US). The FDA issued a Cleared decision on August 13, 1997, 76 days after receiving the submission on May 29, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 862.1660.

Submission Details

510(k) Number K972182 FDA.gov
FDA Decision Cleared SESE
Date Received May 29, 1997
Decision Date August 13, 1997
Days to Decision 76 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