510(k) K981536
K981536 is an FDA 510(k) premarket notification submitted by Hellen Professional Services for the device "QUANTECH MYOGLOBIN ASSAY". The FDA issued a decision of Substantially Equivalent on June 29, 1998. The device falls under product code MVE (Biosensor, Immunoassay, Myoglobin), a Class II device regulated under 21 CFR 866.5680. Hellen Professional Services has at least 1 other 510(k) clearance on record.
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