510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K010455Substantially Equivalent

Rotachrom Heparin and Sta -Rotachrom Heparin

Diagnostica Stago, Inc., Parisppany NJ / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K010455 is the FDA 510(k) clearance record for ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN, a class II device, cleared for Diagnostica-Stago on under FDA product code KFF (Assay, Heparin). FDA records list 19 510(k) clearances for Diagnostica-Stago, from to . As of , FDA records show no recalls naming K010455.

Clearance record

Decision date
Received
(129 days to decision)
Product code
KFF Assay, Heparin
Regulation
21 CFR 864.7525
Device class
Class II
Review panel
Hematology
Applicant
Diagnostica-Stago 5 Century Dr., Parisppany NJ
510(k) summary
Summary
Third party review
No

Clearances, product code KFF

Trailing 12 months
1 clearance under product code KFF in the twelve months to October 2026, September 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KFF, 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 20261
October 20260