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510(k) K850257

BCS GLUCOSE COLORIMETRIC TEST by Bioclinical Systems, Inc. — Product Code CGA

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 5, 1985
Date Received
January 22, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Glucose Oxidase, Glucose
Device Class
Class II
Regulation Number
862.1345
Review Panel
CH
Submission Type

Other clearances by Bioclinical Systems, Inc.

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  • 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)
  • K854379 — MICRO-ELISA TSH TEST KIT-VISI-CHECK TSH TEST KIT (January 7, 1986)

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