510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
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K163220Substantially Equivalent

Atellica CH Phencyclidine (Pcp)

Siemens Healthcare Diagnostics Inc., Newark DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K163220 is the FDA 510(k) clearance record for Atellica CH Phencyclidine (Pcp), cleared for Siemens Healthcare Diagnostics, Inc. on under FDA product code LCM (Enzyme Immunoassay, Phencyclidine). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics, Inc., from to . As of , FDA records show no recalls naming K163220.

Clearance record

Decision date
Received
(141 days to decision)
Product code
LCM Enzyme Immunoassay, Phencyclidine
Device class
Unclassified
Review panel
Unknown
Applicant
Siemens Healthcare Diagnostics, Inc. 500 Gbc Dr., P.O. Box 6101 Ms 514, Newark DE
510(k) summary
Summary PDF
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