510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K811777Substantially Equivalent

Helena Plasminogen Quiplate Procedure

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

K811777 is the FDA 510(k) clearance record for HELENA PLASMINOGEN QUIPLATE PROCEDURE, a class I device, cleared for Helena Laboratories on under FDA product code DDX (Plasminogen, Antigen, Antiserum, Control). FDA records list 282 510(k) clearances for Helena Laboratories, from to . As of , FDA records show no recalls naming K811777.

Clearance record

Decision date
Received
(9 days to decision)
Product code
DDX Plasminogen, Antigen, Antiserum, Control
Regulation
21 CFR 866.5715
Device class
Class I
Review panel
Immunology
Applicant
Helena Laboratories 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code DDX

Trailing 12 months

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

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