510(k) K981373
K981373 is an FDA 510(k) premarket notification submitted by Metra Biosystems, Inc. for the device "ALKPHASE-B ASSAY KIT". The FDA issued a decision of Substantially Equivalent on May 27, 1998. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Metra Biosystems, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 27, 1998
- Date Received
- April 16, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
- Device Class
- Class II
- Regulation Number
- 862.1050
- Review Panel
- CH
- Submission Type