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510(k) K854379

MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT by Bioclinical Systems, Inc. — Product Code JLW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1986
Date Received
October 30, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Thyroid-Stimulating Hormone
Device Class
Class II
Regulation Number
862.1690
Review Panel
CH
Submission Type

Other clearances by Bioclinical Systems, Inc.

  • K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (June 30, 1995)
  • K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (April 4, 1995)
  • K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (February 9, 1994)
  • K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (February 3, 1994)
  • K873086 — ROUND 1 (August 24, 1987)
  • K860333 — MICRO-ELISA HLH TEST KIT MONOCLONAL (April 21, 1986)
  • K860334 — VISI-CHECK HLH TEST MONOCLONAL (April 21, 1986)
  • K855227 — MICRO-EIA THEOPHYLLINE TEST KIT MONOCLONAL (April 11, 1986)
  • K854059 — MICRO-ELISA HCG EST KIT VISI-CHECK HCG TEST KIT NO (January 13, 1986)
  • K850257 — BCS GLUCOSE COLORIMETRIC TEST (March 5, 1985)

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