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510(k) K841834

CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP by Microline Scientific — Product Code JTZ

K841834 is an FDA 510(k) premarket notification submitted by Microline Scientific for the device "CULTURE MEDIUM FOR ANTIMICROBIAL SUSCEP". The FDA issued a decision of Substantially Equivalent on May 14, 1984. 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. Microline Scientific has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 14, 1984
Date Received
April 17, 1984
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 Microline Scientific

  • K841842 — DIFFERENTIAL CULTURE MED. MACCONKEY AGAR (May 31, 1984)
  • K841845 — SELECTIVE CULTURE MED. COLUMBIA CNA (May 31, 1984)
  • K841586 — CHOCOLATE AGAR (May 31, 1984)
  • K841843 — DIFFERENTIAL CULTURE MED. LEVINE EMB (May 31, 1984)
  • K841844 — DIFFERENTIAL CULTURE MEDIUM-BIGGY AGAR (May 31, 1984)
  • K841839 — SELECTIVE CULTURE MED. SELECTIVE STREP (May 25, 1984)
  • K841841 — DIFFERENTIAL CULTURE MED. MANNITOL SALT (May 25, 1984)
  • K841840 — SELECTIVE CULTURE MED. PHENYLETHYL ALCO (May 25, 1984)
  • K841838 — ENRICHED CULTURE MED. TRYPTIC SOY AGAR (May 21, 1984)
  • K841837 — ENRICHED CULTURE MED. FLUID THIOGLYC0 (May 21, 1984)

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