510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K893905Substantially Equivalent

Pathodx(tm) Chlamydia Direct Specimen (Pdcy1)

Siemens Healthcare Diagnostics Inc., Los Angeles CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K893905 is the FDA 510(k) clearance record for PATHODX(TM) CHLAMYDIA DIRECT SPECIMEN (PDCY1), a class I device, cleared for Diagnostic Products Corp. on under FDA product code LIO (Device, Specimen Collection). FDA records list 1,204 510(k) clearances for Siemens Healthcare Diagnostics Inc., from to . As of , FDA records show no recalls naming K893905.

Clearance record

Decision date
Received
(65 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Diagnostic Products Corp. 5700 W. 96th St., Los Angeles CA
Third party review
No

Clearances, product code LIO

Trailing 12 months

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

FDA records show no clearances under product code LIO in the twelve months to November 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIO, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260
November 20260