510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K981536Substantially Equivalent

Quantech Myoglobin Assay

Hellen Professional Services, Northridge CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K981536 is the FDA 510(k) clearance record for QUANTECH MYOGLOBIN ASSAY, a class II device, cleared for Hellen Professional Services on under FDA product code MVE (Biosensor, Immunoassay, Myoglobin). FDA records list 2 510(k) clearances for Hellen Professional Services, from to . As of , FDA records show no recalls naming K981536.

Clearance record

Decision date
Received
(61 days to decision)
Product code
MVE Biosensor, Immunoassay, Myoglobin
Regulation
21 CFR 866.5680
Device class
Class II
Review panel
Immunology
Applicant
Hellen Professional Services 9418 Lasaine Ave., Northridge CA
510(k) summary
Summary
Third party review
No

Clearances, product code MVE

Trailing 12 months

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

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