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510(k) K801901

MUELLER HINTON AGAR by Radiation Technology, Inc. — Product Code JTZ

K801901 is an FDA 510(k) premarket notification submitted by Radiation Technology, Inc. for the device "MUELLER HINTON AGAR". The FDA issued a decision of Substantially Equivalent on August 20, 1980. 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. Radiation Technology, Inc. has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1980
Date Received
August 8, 1980
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 Radiation Technology, Inc.

  • K910648 — THERAPY CHAIR SYSTEM (July 22, 1991)
  • K802892 — CULTURE MEDIA FOR IN VITRO DIAG. USE (December 11, 1980)
  • K801943 — BRAIN HEART INFUSION MICROBIOLOGICAL (September 9, 1980)
  • K801817 — MICROBIOLOGY CULTURE MEDIA, C.L.E.D. (August 27, 1980)
  • K801772 — MICROBIOLOGY CULTURE MEDIA-MACCONKEY AG (August 20, 1980)
  • K801847 — TRIPLE SUGAR IRON AGAR(MICRO/CULT/MEDIA (August 13, 1980)

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