Cleared Traditional

PLATELET AGGREGATION PROFILER MODEL PAP-4C

K893650 · Bio/Data Corp. · Hematology
Jun 1989
Decision
39d
Days
Class 2
Risk

About This 510(k) Submission

K893650 is an FDA 510(k) clearance for the PLATELET AGGREGATION PROFILER MODEL PAP-4C, a System, Multipurpose For In Vitro Coagulation Studies (Class II — Special Controls, product code JPA), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on June 23, 1989, 39 days after receiving the submission on May 15, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5425.

Submission Details

510(k) Number K893650 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1989
Decision Date June 23, 1989
Days to Decision 39 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPA — System, Multipurpose For In Vitro Coagulation Studies
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5425

Similar Devices — JPA System, Multipurpose For In Vitro Coagulation Studies

All 179
Automated Blood Coagulation Analyzer CN-Series (CN-6000)
K250965 · Sysmex America, Inc. · Jun 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K251024 · Haemonetics · Apr 2025
TEG 6s Hemostasis System Citrated: K, KH, RT, FF Assay Cartridge
K243858 · Haemonetics Corporation · Jan 2025
Citrated: K, KH, RTH, FFH
K232018 · Haemonetics Corporation · Mar 2024
ACL TOP 970 CL
K233790 · Instrumentation Laboratory · Dec 2023
ACL TOP 970 CL, HemosIL CL Anti-Cardiolipin IgM, HemosIL CL Anti-?2 Glycoprotein-I IgM
K221359 · Instrumentation Laboratory CO · Sep 2023