510(K) CLEARANCES 51 ▲2RECALLS POSTED 25 ▲2CLASS I 1PMA DECISIONS 50 ▲13WEEK ENDING / FDA DATA AS OF
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K090737Substantially Equivalent

Hemoglobin Capillary Collection System (Hccs), 1 Test, Hemoglobin Capillary Collection System (Hccs), 5 Tests, Hemoglobi

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

K090737 is the FDA 510(k) clearance record for HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 1 TEST, HEMOGLOBIN CAPILLARY COLLECTION SYSTEM (HCCS), 5 TESTS, HEMOGLOBI, a class II device, cleared for Bio-Rad Laboratories, Inc. on under FDA product code JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection). FDA records list 128 510(k) clearances for Bio-Rad Laboratories, Inc., from to . As of , FDA records show no recalls naming K090737.

Clearance record

Decision date
Received
(75 days to decision)
Product code
JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
Regulation
21 CFR 862.1675
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Bio-Rad Laboratories, Inc. 4000 Alfred Nobel Dr., Hercules CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code JKA

Trailing 12 months
8 clearances under product code JKA in the twelve months to November 2026, April 2026 the highest month at 3.
Show the numbers
Monthly 510(k) clearances under FDA product code JKA, trailing twelve months
MonthClearances
December 20250
January 20260
February 20260
March 20261
April 20263
May 20260
June 20261
July 20260
August 20260
September 20261
October 20262
November 20260