510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K011161Substantially Equivalent

Modification to the Emit II Plus Phencyclidine Assay, Model Osr9j229

Syva Co., Dade Behring, Inc., San Jose CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K011161 is the FDA 510(k) clearance record for MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL OSR9J229, cleared for Syva Co., Dade Behring, Inc. on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 19 510(k) clearances for Syva Co., Dade Behring, Inc., from to . As of , FDA records show no recalls naming K011161.

Clearance record

Decision date
Received
(29 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Syva Co., Dade Behring, Inc. 3403 Yerba Buena Rd., San Jose CA
510(k) summary
Summary
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