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510(k) K781607

STREP-TEX by Burroughs Wellcome Co. — Product Code GTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 17, 1978
Date Received
September 18, 1978
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

Other clearances by Burroughs Wellcome Co.

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  • K810215 — DAC-CEL HCG (April 17, 1981)
  • K810214 — DAC-CEL DIAGNATAL (March 6, 1981)
  • K810212 — DAC-CEL T3 UPTAKE (February 10, 1981)
  • K810213 — DAC-CEL TSH (February 10, 1981)
  • K791232 — DAC-CEL T3 (September 4, 1979)
  • K791231 — DAC-CEL T4 (September 4, 1979)
  • K780874 — THYMUNE-T (June 14, 1978)
  • K780873 — THYMUNE-M (June 14, 1978)

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  • K962060 — STREP A OIA MAX (July 23, 1997)
  • K962296 — STREPTOLEX-STAT (December 16, 1996)
  • K961423 — OSOM STREP A TEST (October 11, 1996)
  • K962146 — EXCEL ONESTEP GROUP A STREP ANTIGEN MODULE TEST KIT (October 7, 1996)
  • K955108 — CARDS Q.S. STREP A (April 15, 1996)