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510(k) K854275

THAYER-MARTIN MEDIUM (MOD) by R. Kent Richards, Inc. — Product Code JTY

K854275 is an FDA 510(k) premarket notification submitted by R. Kent Richards, Inc. for the device "THAYER-MARTIN MEDIUM (MOD)". The FDA issued a decision of Substantially Equivalent on November 12, 1985. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. R. Kent Richards, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1985
Date Received
October 18, 1985
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 R. Kent Richards, Inc.

  • K871065 — CHLAMYDIA & VIRAL TRANSPORT MEDIUM (April 14, 1987)
  • K854452 — MANNITOL SALT AGAR (November 18, 1985)
  • K854454 — TRYPTIC SOY BLOOD AGAR (November 18, 1985)
  • K854451 — MUELLER HINTON MEDIUM (November 18, 1985)
  • K854455 — CDC ANAEROBE BLOOD AGAR (November 18, 1985)
  • K854457 — COLUMBIA CNA AGAR W/5% SHEEP BLOOD (November 18, 1985)
  • K854456 — CAMPYLOBACTER BLOOD AGAR (November 18, 1985)
  • K854453 — P.E.Z. AGAR (PHENYLETHANOL AGAR) (November 18, 1985)
  • K854450 — BILE ESCULIN AZIDE AGAR (November 18, 1985)
  • K854449 — HEKTOEN ENTERIC AGAR (November 18, 1985)

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