Cleared Traditional

K971522 - ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II (FDA 510(k) Clearance)

K971522 · Abbott Laboratories · Microbiology device

Mar 1998

Decision

312d

Days

Class 1

Risk

K971522 is an FDA 510(k) clearance for the ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II. This device is classified as 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 FDA review panel. Regulated under 21 CFR 866.3740.

Submission Details

510(k) Number	K971522 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (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