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510(k) K945911

CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS by Bioclinical Systems, Inc. — Product Code JTZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 4, 1995
Date Received
December 2, 1994
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth
Device Class
Class II
Regulation Number
866.1700
Review Panel
MI
Submission Type

Other clearances by Bioclinical Systems, Inc.

  • K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (June 30, 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)
  • K860334 — VISI-CHECK HLH TEST MONOCLONAL (April 21, 1986)
  • K860333 — MICRO-ELISA HLH TEST KIT 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)
  • K850257 — BCS GLUCOSE COLORIMETRIC TEST (March 5, 1985)

Other clearances for product code JTZ

  • K132491 — MUELLER HINTON AGAR (June 30, 2014)
  • K963036 — MUELLER HINTON II BROTH (CATION-ADJUSTED) WITH LYSED HORSE BLOOD (October 7, 1996)
  • K960420 — MUELLER HINTON AGAR WITH 5% SHEEP BLOOD (April 4, 1996)
  • K960313 — MUELLER HINTON AGAR WITH 2% NACI (March 25, 1996)
  • K941985 — MUELLER HINTON AGAR W/OXACILLIN (August 24, 1994)
  • K882351 — MUELLER HINTON AGAR PLATES P3318/1&2/P3418/P34181 (June 28, 1988)
  • K880105 — MULLER HINTON BROTH (March 30, 1988)
  • K873268 — MUELLER HINTON MEDIA (November 4, 1987)
  • K870649 — MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) (April 14, 1987)
  • K871097 — CHOCOLATE MUELLER HINTON AGAR (April 3, 1987)