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510(k) K861301

BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 by Troy Biologicals, Inc. — Product Code JTZ

K861301 is an FDA 510(k) premarket notification submitted by Troy Biologicals, Inc. for the device "BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000". The FDA issued a decision of Substantially Equivalent on April 21, 1986. 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. Troy Biologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1986
Date Received
April 7, 1986
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 Troy Biologicals, Inc.

  • K832860 — SXT BLOOD AGAR (September 26, 1983)
  • K832862 — TRANSGROW MEDIUM (September 26, 1983)
  • K832861 — SABOURAUD DEXTROSE AGAR (September 26, 1983)
  • K832863 — STREP ID QUAD (September 26, 1983)
  • K823310 — STREPTOCOCCUS SELECTIVE AGAR (December 15, 1982)
  • K823307 — CAMPYLOBACTER SELECTIVE AGAR (December 15, 1982)
  • K823311 — COLUMBIA V AGAR W/5% HUMAN BLOOD (December 15, 1982)
  • K823306 — HEMOPHILUS QUAD 10 PLATE (December 15, 1982)
  • K823309 — MARTIN & LEMIS AGAR W/VCAT INHIBITOR (December 3, 1982)
  • K823308 — MYCAREL AGAR MYCOBROTIC AGAR (December 3, 1982)

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