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510(k) K854451

MUELLER HINTON MEDIUM by R. Kent Richards, Inc. — Product Code JTZ

K854451 is an FDA 510(k) premarket notification submitted by R. Kent Richards, Inc. for the device "MUELLER HINTON MEDIUM". The FDA issued a decision of Substantially Equivalent on November 18, 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. R. Kent Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 18, 1985
Date Received
November 5, 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 R. Kent Richards, Inc.

  • K871065 — CHLAMYDIA & VIRAL TRANSPORT MEDIUM (April 14, 1987)
  • K854452 — MANNITOL SALT AGAR (November 18, 1985)
  • K854454 — TRYPTIC SOY BLOOD AGAR (November 18, 1985)
  • K854455 — CDC ANAEROBE BLOOD AGAR (November 18, 1985)
  • K854456 — CAMPYLOBACTER BLOOD AGAR (November 18, 1985)
  • K854449 — HEKTOEN ENTERIC AGAR (November 18, 1985)
  • K854457 — COLUMBIA CNA AGAR W/5% SHEEP BLOOD (November 18, 1985)
  • K854453 — P.E.Z. AGAR (PHENYLETHANOL AGAR) (November 18, 1985)
  • K854450 — BILE ESCULIN AZIDE AGAR (November 18, 1985)
  • K854275 — THAYER-MARTIN MEDIUM (MOD) (November 12, 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