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510(k) K850843

MUELLER HINTON CHOCOLATE AGAR by Micro Media Laboratories — Product Code JTZ

K850843 is an FDA 510(k) premarket notification submitted by Micro Media Laboratories for the device "MUELLER HINTON CHOCOLATE AGAR". 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. Micro Media Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 20, 1985
Date Received
March 1, 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 Micro Media Laboratories

  • K853691 — TERGITOL 7 AGAR (September 17, 1985)
  • K853690 — COLUMBIZ BLOOD AGAR (September 17, 1985)
  • K851344 — OXIDATIVE FORMENTIVE MEDIUM (April 22, 1985)
  • K851347 — KANAMYCIN-VANCOMYCIN-LAKED BLOOD AGAR (April 19, 1985)
  • K851345 — PURPLE BROTH (April 19, 1985)
  • K851348 — COBA AGAR (April 19, 1985)
  • K851346 — PHENYLALANINE AGAR (April 19, 1985)
  • K851343 — BROM CRESOL PURPLE STARCH (April 19, 1985)
  • K850845 — 0.85% SALINE (March 20, 1985)
  • K850844 — V AGAR (March 20, 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