510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103555Substantially Equivalent

Multiplate 5.0 Aggregometer

Verum Diagnostica GmbH, Munich, DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103555 is the FDA 510(k) clearance record for MULTIPLATE 5.0 AGGREGOMETER, a class II device, cleared for Verum Diagnostica GmbH on under FDA product code JOZ (System, Automated Platelet Aggregation). FDA records list one 510(k) clearance for Verum Diagnostica GmbH. As of , FDA records show no recalls naming K103555.

Clearance record

Decision date
Received
(602 days to decision)
Product code
JOZ System, Automated Platelet Aggregation
Regulation
21 CFR 864.5700
Device class
Class II
Review panel
Hematology
Applicant
Verum Diagnostica GmbH Reichenbachstrasse 27, Munich, DE
510(k) summary
Summary PDF
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