510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K852185Substantially Equivalent

Respiratory Syncytial Virus Direct Fluorescent Ant

Bartels Immunodiagnostic Supplies, Inc., Bellevue WA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K852185 is the FDA 510(k) clearance record for RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT, a class I device, cleared for Bartels Immunodiagnostic Supplies, Inc. on under FDA product code LKT (Respiratory Syncytial Virus, Antigen, Antibody, Ifa). FDA records list 35 510(k) clearances for Bartels Immunodiagnostic Supplies, Inc., from to . As of , FDA records show no recalls naming K852185.

Clearance record

Decision date
Received
(91 days to decision)
Product code
LKT Respiratory Syncytial Virus, Antigen, Antibody, Ifa
Regulation
21 CFR 866.3480
Device class
Class I
Review panel
Microbiology
Applicant
Bartels Immunodiagnostic Supplies, Inc. P.O. Box 3093, Bellevue WA
Third party review
No

Clearances, product code LKT

Trailing 12 months

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

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