510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K071255Substantially Equivalent

Zymutest Hia Iggam, Zymutest Igg, Model Rk040d, Rk040a

Hyphen Biomed Sasu, Mason OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K071255 is the FDA 510(k) clearance record for ZYMUTEST HIA IGGAM, ZYMUTEST IGG, MODEL RK040D, RK040A, a class II device, cleared for Hyphen Biomed on under FDA product code LCO (Platelet Factor 4 Radioimmunoassay). FDA records list 6 510(k) clearances for HYPHEN BIOMED SASU, from to . As of , FDA records show 8 recalls naming K071255.

Clearance record

Decision date
Received
(126 days to decision)
Product code
LCO Platelet Factor 4 Radioimmunoassay
Regulation
21 CFR 864.7695
Device class
Class II
Review panel
Hematology
Applicant
Hyphen Biomed 6560 Gove Ct., Mason OH
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LCO

Trailing 12 months

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

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