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510(k) K935667

QTEST(R) STREP by Becton Dickinson Advanced Diagnostics — Product Code GTY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1994
Date Received
November 26, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

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

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  • K923673 — PRECISE STREP A (September 28, 1992)
  • K923060 — IQ IMMUNOCHEMISTRY SISTEM; IQ TSH ASSAY (September 15, 1992)
  • K914958 — RIATRAC PLUS (March 18, 1992)
  • K915197 — PRECISE TM HCG (December 17, 1991)
  • K915200 — PRECISE TM HCG FOR USE IN THE PHYSICIANS OFFICE LA (December 16, 1991)

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