510(k) K010562
K010562 is an FDA 510(k) premarket notification submitted by First Medical, Inc. for the device "ALPHA DX SYSTEM". The FDA issued a decision of Substantially Equivalent on March 13, 2001. The device falls under product code MMI (Immunoassay Method, Troponin Subunit), a Class II device regulated under 21 CFR 862.1215. First Medical, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 13, 2001
- Date Received
- February 26, 2001
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Immunoassay Method, Troponin Subunit
- Device Class
- Class II
- Regulation Number
- 862.1215
- Review Panel
- CH
- Submission Type