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510(k) K853238

APL MUELLER HINTON AGAR by Apl Medical Supplies — Product Code JTZ

K853238 is an FDA 510(k) premarket notification submitted by Apl Medical Supplies for the device "APL MUELLER HINTON AGAR". The FDA issued a decision of Substantially Equivalent on August 19, 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. Apl Medical Supplies has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 19, 1985
Date Received
August 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 Apl Medical Supplies

  • K853618 — APL SIM MEDIUM (September 16, 1985)
  • K853617 — APL SIMMONS CITRATE AGAR (September 16, 1985)
  • K853610 — APL MOTILITY INDOLE ORNITHINE AGAR (September 16, 1985)
  • K853619 — APL TRIPLE SUGAR IRON AGAR (September 16, 1985)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K853611 — APL XYLOSE LYSINE DEOXYCHOLATE AGAR (September 12, 1985)
  • K853613 — APL GN BROTH (September 6, 1985)
  • K853616 — APL CHLAMYDOSPORE AGAR (September 6, 1985)
  • K853612 — APL DNASE TEST AGAR (September 6, 1985)
  • K853615 — APL BILE ESCULIN/AZIDE AGAR (September 6, 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