510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K091303Substantially Equivalent

Liquichek Hematology-16 Control Lv, Model: 295Lv

Bio-Rad Laboratories Inc., Irvine CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K091303 is the FDA 510(k) clearance record for LIQUICHEK HEMATOLOGY-16 CONTROL LV, MODEL: 295LV, a class II device, cleared for Bio-Rad Laboratories on under FDA product code JPK (Mixture, Hematology Quality Control). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, from to . As of , FDA records show no recalls naming K091303.

Clearance record

Decision date
Received
(455 days to decision)
Product code
JPK Mixture, Hematology Quality Control
Regulation
21 CFR 864.8625
Device class
Class II
Review panel
Hematology
Applicant
Bio-Rad Laboratories 9500 Jeronimo Rd., Irvine CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JPK

Trailing 12 months

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

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