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510(k) K993033

INTRAY GC by Biomed Diagnostics, Inc. — Product Code JTY

K993033 is an FDA 510(k) premarket notification submitted by Biomed Diagnostics, Inc. for the device "INTRAY GC". The FDA issued a decision of Substantially Equivalent on December 16, 1999. The device falls under product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria), a Class II device regulated under 21 CFR 866.2410. Biomed Diagnostics, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 16, 1999
Date Received
September 9, 1999
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 Biomed Diagnostics, Inc.

  • K896296 — INPOUCH-TV POUCH (January 29, 1990)

Other clearances for product code JTY

  • K210511 — InTray GC (October 20, 2021)
  • 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