510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K800037Substantially Equivalent

Platelet Retention (Adhesion) Columns

Hemometrix, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K800037 is the FDA 510(k) clearance record for PLATELET RETENTION (ADHESION) COLUMNS, a class II device, cleared for Hemometrix on under FDA product code JBZ (Study, Platelet Adhesive). FDA records list 7 510(k) clearances for Hemometrix, from to . As of , FDA records show no recalls naming K800037.

Clearance record

Decision date
Received
(29 days to decision)
Product code
JBZ Study, Platelet Adhesive
Regulation
21 CFR 864.6650
Device class
Class II
Review panel
Hematology
Applicant
Hemometrix 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JBZ

Trailing 12 months

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

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