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510(k) K210511

InTray GC by Biomed Diagnostics Incorporated — Product Code JTY

K210511 is an FDA 510(k) premarket notification submitted by Biomed Diagnostics Incorporated for the device "InTray GC". The FDA issued a decision of Substantially Equivalent on October 20, 2021. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 20, 2021
Date Received
February 23, 2021
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 for product code JTY

  • 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)
  • K881527 — CASMAN MEDIUM BASE (April 18, 1988)

FDA data resources