510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K854615Substantially Equivalent

Monabrite Chlamydia Trach Culture Confirmation Tes

Serono Diagnostics, Inc., Bramtree MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K854615 is the FDA 510(k) clearance record for MONABRITE CHLAMYDIA TRACH CULTURE CONFIRMATION TES, a class I device, cleared for Serono Diagnostics, Inc. on under FDA product code LKI (Antisera, Fluorescent, Chlamydia Spp.). FDA records list 25 510(k) clearances for Serono Diagnostics, Inc., from to . As of , FDA records show no recalls naming K854615.

Clearance record

Decision date
Received
(71 days to decision)
Product code
LKI Antisera, Fluorescent, Chlamydia Spp.
Regulation
21 CFR 866.3120
Device class
Class I
Review panel
Microbiology
Applicant
Serono Diagnostics, Inc. 11 Brooks Dr., Bramtree MA
Third party review
No

Clearances, product code LKI

Trailing 12 months

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

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