510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K900225Substantially Equivalent

Romcheck Specimen Collection Kit

Adeza Biomedical, Sunnyvale CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900225 is the FDA 510(k) clearance record for ROMCHECK SPECIMEN COLLECTION KIT, a class I device, cleared for Adeza Biomedical on under FDA product code LIO (Device, Specimen Collection). FDA records list 3 510(k) clearances for Adeza Biomedical, from to . As of , FDA records show 2 recalls naming K900225.

Clearance record

Decision date
Received
(16 days to decision)
Product code
LIO Device, Specimen Collection
Regulation
21 CFR 866.2900
Device class
Class I
Review panel
Microbiology
Applicant
Adeza Biomedical 1240 Elko Dr., Sunnyvale 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 October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIO, 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