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510(k) K823309

MARTIN & LEMIS AGAR W/VCAT INHIBITOR by Troy Biologicals, Inc. — Product Code JTY

K823309 is an FDA 510(k) premarket notification submitted by Troy Biologicals, Inc. for the device "MARTIN & LEMIS AGAR W/VCAT INHIBITOR". The FDA issued a decision of Substantially Equivalent on December 3, 1982. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Troy Biologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 3, 1982
Date Received
November 5, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, For Isolation Of Pathogenic Neisseria
Device Class
Class II
Regulation Number
866.2410
Review Panel
MI
Submission Type

Other clearances by Troy Biologicals, Inc.

  • K861301 — BACTI PLATE (DERMATOLOGY) PRODUCT NO. PS-5000 (April 21, 1986)
  • K832863 — STREP ID QUAD (September 26, 1983)
  • K832861 — SABOURAUD DEXTROSE AGAR (September 26, 1983)
  • K832860 — SXT BLOOD AGAR (September 26, 1983)
  • K832862 — TRANSGROW MEDIUM (September 26, 1983)
  • K823306 — HEMOPHILUS QUAD 10 PLATE (December 15, 1982)
  • 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)
  • K823308 — MYCAREL AGAR MYCOBROTIC AGAR (December 3, 1982)

Other clearances for product code JTY

  • K210511 — InTray GC (October 20, 2021)
  • K993033 — INTRAY GC (December 16, 1999)
  • K954986 — GC BASE W/ 1% GCHI (February 16, 1996)
  • K950196 — CULTURE MEDIA, FOR ISOLATION OF PATHOGENIC NEISSERIA (June 30, 1995)
  • K933122 — MICROBIOLOGICAL CULTURE MEDIA,MARTIN LEWIS AGAR (February 9, 1994)
  • K933121 — MICROBIOLOGICAL CULTURE MEDIA,CHOCOLATE AGAR (February 3, 1994)
  • K934331 — THAYER MARTIN, MODIFIED PILL POCKET (December 21, 1993)
  • K934330 — TRANSGROW (December 17, 1993)
  • K931864 — MARTIN LEWIS WITH LINOCMYCIN (December 15, 1993)
  • K881552 — PROTEOSE NO. 3 AGAR (April 18, 1988)

FDA data resources