510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K853548Substantially Equivalent

Stratus Procainamide Fluorometric Enzyme Immunoass

American Dade, Santa Ana CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K853548 is the FDA 510(k) clearance record for STRATUS PROCAINAMIDE FLUOROMETRIC ENZYME IMMUNOASS, cleared for American Dade on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 149 510(k) clearances for American Dade, from to . As of , FDA records show no recalls naming K853548.

Clearance record

Decision date
Received
(23 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
American Dade P.O. Box 25101, Santa Ana CA
Third party review
No

Clearances, product code LCM

Trailing 12 months

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

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