Home / 510(k) Clearances / K981536

510(k) K981536

QUANTECH MYOGLOBIN ASSAY by Hellen Professional Services — Product Code MVE

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 29, 1998
Date Received
April 29, 1998
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Biosensor, Immunoassay, Myoglobin
Device Class
Class II
Regulation Number
866.5680
Review Panel
IM
Submission Type

Other clearances by Hellen Professional Services

  • K020226 — XENOSTRIP-TV TRICHOMONAS DIAGNOSTIC TEST KIT; CATALOG NUMBERS S1383.01, S1383.02 (August 22, 2002)