Home / 510(k) Clearances / K873268

510(k) K873268

MUELLER HINTON MEDIA by Central Media — Product Code JTZ

K873268 is an FDA 510(k) premarket notification submitted by Central Media for the device "MUELLER HINTON MEDIA". The FDA issued a decision of Substantially Equivalent on November 4, 1987. 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. Central Media has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1987
Date Received
August 11, 1987
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 Central Media

  • K873258 — STREPTOCOCCAL SELECTIVE DIFFEREN. & ENRICHED MEDIA (November 6, 1987)
  • K873259 — SPECIALTY MEDIA (November 6, 1987)
  • K873257 — GENERAL PURPOSE MEDIA W/SELECT. & DIFF. MODIFICA. (November 6, 1987)
  • K873260 — CORYNEBACTERIA ISOLATION MEDIA (November 6, 1987)
  • K873270 — ACTINOMYCETE DIFFERENTIAL MEDIA (November 4, 1987)
  • K873267 — ECG BASED MEDIA (November 4, 1987)
  • K873269 — MYCOLOGICAL MEDIA (November 4, 1987)
  • K873266 — MIDDLEBROOK BASED MEDIA (October 28, 1987)
  • K873264 — MEDIA FOR DETECTION & VERIFICATION OF COLIFORMS (October 28, 1987)
  • K873263 — MAINTENANCE & CARBOHYDRATE FERMENTATION MEDIA (October 28, 1987)

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)
  • K870649 — MRSA SCREEN AGAR (MUELLER HINTON W/NACL & OXACIL.) (April 14, 1987)
  • K871097 — CHOCOLATE MUELLER HINTON AGAR (April 3, 1987)

FDA data resources