Home / 510(k) Clearances / K971522

510(k) K971522

ABBOTT TESTPACK PLUS STREP A WITH ON BOARD CONTROLS (OBC) II by Abbott Laboratories — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1998
Date Received
April 25, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, All Groups, Streptococcus Spp.
Device Class
Class I
Regulation Number
866.3740
Review Panel
MI
Submission Type

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  • K962060 — STREP A OIA MAX (July 23, 1997)
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  • K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (October 7, 1996)
  • K955108 — CARDS Q.S. STREP A (April 15, 1996)
  • K960712 — BINAX STREP A TEST (March 22, 1996)