510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K993033Substantially Equivalent

Intray Gc

Biomed Diagnostics, Inc., San Jose CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K993033 is the FDA 510(k) clearance record for INTRAY GC, a class II device, cleared for Biomed Diagnostics, Inc. on under FDA product code JTY (Culture Media, For Isolation Of Pathogenic Neisseria). FDA records list 2 510(k) clearances for Biomed Diagnostics, Inc., from to . As of , FDA records show no recalls naming K993033.

Clearance record

Decision date
Received
(98 days to decision)
Product code
JTY Culture Media, For Isolation Of Pathogenic Neisseria
Regulation
21 CFR 866.2410
Device class
Class II
Review panel
Microbiology
Applicant
Biomed Diagnostics, Inc. 1430 Koll Cir., Suite 101, San Jose CA
510(k) summary
Summary
Third party review
No

Clearances, product code JTY

Trailing 12 months

FDA records hold no clearances under product code JTY in the trailing twelve months.

FDA records show no clearances under product code JTY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JTY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260