510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K781693Substantially Equivalent

Collagenreagent Horm

Hormon-Chemie Munchem Gmch, Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K781693 is the FDA 510(k) clearance record for COLLAGENREAGENT HORM, a class II device, cleared for Hormon-Chemie Munchem Gmch on under FDA product code JOZ (System, Automated Platelet Aggregation). FDA records list one 510(k) clearance for Hormon-Chemie Munchem Gmch. As of , FDA records show no recalls naming K781693.

Clearance record

Decision date
Received
(64 days to decision)
Product code
JOZ System, Automated Platelet Aggregation
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Applicant
Hormon-Chemie Munchem Gmch 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code JOZ

Trailing 12 months

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

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