Cleared Traditional

K790769 - BETA/PAK
(FDA 510(k) Clearance)

K790769 · Bio/Data Corp. · Hematology
May 1979
Decision
14d
Days
Class 2
Risk

K790769 is an FDA 510(k) clearance for the BETA/PAK, a System, Automated Platelet Aggregation (Class II — Special Controls, product code JOZ), submitted by Bio/Data Corp. (Mchenry, US). The FDA issued a Cleared decision on May 3, 1979, 14 days after receiving the submission on April 19, 1979. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5700.

Submission Details

510(k) Number K790769 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1979
Decision Date May 03, 1979
Days to Decision 14 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JOZ — System, Automated Platelet Aggregation
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5700

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