510(k) K874373
K874373 is an FDA 510(k) premarket notification submitted by Probe-Tek, Inc. for the device "PT PRO-CLOT". The FDA issued a decision of Substantially Equivalent on January 5, 1988. The device falls under product code JBR (Test, Heparin Neutralization), a Class II device regulated under 21 CFR 864.7525. Probe-Tek, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 5, 1988
- Date Received
- October 26, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Heparin Neutralization
- Device Class
- Class II
- Regulation Number
- 864.7525
- Review Panel
- HE
- Submission Type