510(k) K893650

PLATELET AGGREGATION PROFILER MODEL PAP-4C by Bio/Data Corp. — Product Code JPA

K893650 is an FDA 510(k) premarket notification submitted by Bio/Data Corp. for the device "PLATELET AGGREGATION PROFILER MODEL PAP-4C". The FDA issued a decision of Substantially Equivalent on June 23, 1989. The device falls under product code JPA (System, Multipurpose For In Vitro Coagulation Studies), a Class II device regulated under 21 CFR 864.5425. Bio/Data Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 23, 1989
Date Received
May 15, 1989
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