510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K031947Substantially Equivalent

Bayer Clinitek Status Analyzer

Medrad, Inc., Medfield MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031947 is the FDA 510(k) clearance record for BAYER CLINITEK STATUS ANALYZER, a class I device, cleared for Bayer Healthcare, LLC on under FDA product code KQO (Automated Urinalysis System). FDA records list 177 510(k) clearances for Medrad, Inc., from to . As of , FDA records show no recalls naming K031947.

Clearance record

Decision date
Received
(178 days to decision)
Product code
KQO Automated Urinalysis System
Regulation
21 CFR 862.2900
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Bayer Healthcare, LLC 63 N. St., Medfield MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KQO

Trailing 12 months

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

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