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510(k) K850731

CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING by Roseville Medical Laboratoriesu — Product Code JTZ

K850731 is an FDA 510(k) premarket notification submitted by Roseville Medical Laboratoriesu for the device "CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP. TESTING". The FDA issued a decision of Substantially Equivalent on March 20, 1985. The device falls under product code JTZ (Culture Media, Antimicrobial Susceptibility Test, Mueller Hinton Agar/Broth), a Class II device regulated under 21 CFR 866.1700. Roseville Medical Laboratoriesu has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
February 20, 1985
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 Roseville Medical Laboratoriesu

  • K850734 — DIFFERENTIAL CULTURE MEDIUM (March 20, 1985)
  • K850733 — MULTIPURPOSE CULTURE MEDIUM (March 20, 1985)
  • K850732 — CULTURE MEDIUM FOR PATHOGENIC NEISSERIA SSP.MI (March 20, 1985)
  • K850738 — SUPPLEMENT FOR CULTURE MEDIUM (March 20, 1985)
  • K850736 — SELECTIVE CULTURE MEDIUM (March 20, 1985)
  • K850737 — TRANSPORT CULTURE MEDIUM (March 20, 1985)
  • K850735 — ENRICHED CULTURE MEDIUM (March 16, 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)
  • K945911 — CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, MUELLER HINTON AGARS (April 4, 1995)
  • 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)

FDA data resources