510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K862354Substantially Equivalent

Monofluor Chlamydia Trachomatis Dir Spec Test Kit

Synbiotics Corp., San Diego CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862354 is the FDA 510(k) clearance record for MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT, a class I device, cleared for Synbiotics Corp. on under FDA product code LJP (Antiserum, Fluorescent, Chlamydia Trachomatis). FDA records list 3 510(k) clearances for Synbiotics Corp., from to . As of , FDA records show no recalls naming K862354.

Clearance record

Decision date
Received
(101 days to decision)
Product code
LJP Antiserum, Fluorescent, Chlamydia Trachomatis
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Synbiotics Corp. 11011 Via Frontera, San Diego CA
Third party review
No

Clearances, product code LJP

Trailing 12 months

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

FDA records show no clearances under product code LJP in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LJP, 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