Cleared Traditional

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II

K971522 · Abbott Laboratories · Microbiology
Mar 1998
Decision
312d
Days
Class 1
Risk

About This 510(k) Submission

K971522 is an FDA 510(k) clearance for the ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II, a Antisera, All Groups, Streptococcus Spp. (Class I — General Controls, product code GTZ), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on March 3, 1998, 312 days after receiving the submission on April 25, 1997. This device falls under the Microbiology review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number K971522 FDA.gov
FDA Decision Cleared SESE
Date Received April 25, 1997
Decision Date March 03, 1998
Days to Decision 312 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary Summary PDF

Device Classification

Product Code GTZ — Antisera, All Groups, Streptococcus Spp.
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.3740

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