ClearanceBrief
Panels › Microbiology › Product code GTZ · Class 1

Antisera, All Groups, Streptococcus Spp.

Regulation 866.3740

0510(k)s in 12 months (105 all time)
0recalls in 12 months (3 all time)
3recalls that name a 510(k)
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Top companies in GTZ

Company510(k)sRecalls
Abbott Laboratories90
Quidel Corp.80
Bd Becton Dickinson Vacutainer Systems Preanalytic70
Binax, Inc.60
Diagnostic Products Corp.40
Pharmacia, Inc.40
Armkel, LLC30
Difco Laboratories, Inc.30
Leeco Diagnostics, Inc.30
Medix Biotech, Inc.30
Decided510(k)Device and applicantCode
Jun 20, 1980K801159STREPTO-SEC TM
Organon, Inc.
GTZ
Apr 29, 1980K800159PHADEBACT STREP D TEST
Pharmacia, Inc.
GTZ
May 1, 1979K790492SERO-STAT STREPTOCOCCUS TEST
Scott Laboratories, Inc.
GTZ
Oct 17, 1978K781607STREP-TEX
Burroughs Wellcome Co.
GTZ
Aug 3, 1976K760033TEST, ANTIBODIES FOR GRP A, LATEX SLIDE
Gamma Biologicals, Inc.
GTZ

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