510(k) K981536
- Device
- QUANTECH MYOGLOBIN ASSAY
- Applicant
- HELLEN PROFESSIONAL SERVICES
- 510(k) number
- K981536
- Product code
- MVE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1998-06-29
- Date received
- 1998-04-29
- Regulation
- 866.5680
- Classification name
- Biosensor, Immunoassay, Myoglobin
- Medical specialty
- Immunology
- Review panel
- Immunology
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- ROBIN J HELLEN
- Address
- 9418 Lasaine Ave. Northridge CA US 91325 91325
FDA Registration Numbers#
- 3005360469
- 2020726
- 3005984081
Source Documents#
Legacy Summary#
summary
FDA Review#
Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links Follow FDA En Español Home Food Drugs Medical Devices Radiation-Emitting Products Vaccines, Blood & Biologics Animal & Veterinary Cosmetics Tobacco Products FDA Home Medical Devices Databases