510(k) K961573
K961573 is an FDA 510(k) premarket notification submitted by Hybritech, Inc. for the device "TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAY". The FDA issued a decision of Substantially Equivalent on August 19, 1996. The device falls under product code CIN (Electrophoretic Separation, Alkaline Phosphatase Isoenzymes), a Class II device regulated under 21 CFR 862.1050. Hybritech, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 19, 1996
- Date Received
- April 23, 1996
- 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