510(k) K860719
K860719 is an FDA 510(k) premarket notification submitted by Biotrack, Inc. for the device "BIOTRACK PROTIME CONTROLS (BIOTRACK PROTIME TEST)". The FDA issued a decision of Substantially Equivalent on May 23, 1986. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Biotrack, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 23, 1986
- Date Received
- February 26, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Multipurpose For In Vitro Coagulation Studies
- Device Class
- Class II
- Regulation Number
- 864.5425
- Review Panel
- HE
- Submission Type