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510(k) K851225

URINE DUO by Culture Kits, Inc. — Product Code JTZ

K851225 is an FDA 510(k) premarket notification submitted by Culture Kits, Inc. for the device "URINE DUO". The FDA issued a decision of Substantially Equivalent on August 13, 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. Culture Kits, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 1985
Date Received
March 26, 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 Culture Kits, Inc.

  • K911846 — URI-THREE(TM), MODIFICATION (October 4, 1991)
  • K854672 — CANDI-KIT TM (July 11, 1986)
  • K853488 — STAPH KIT (August 28, 1985)
  • K852582 — GONI-KIT (July 12, 1985)
  • K852480 — DERM-KIT (July 9, 1985)
  • K851518 — MUELLER HINTON SENSITIVITY PLATE (April 29, 1985)
  • K850765 — STREP-KIT (April 24, 1985)
  • K850998 — URI-KIT (April 1, 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