Cleared Traditional

PLASTINEX

K852484 · Bio/Data Corp. · Hematology
Aug 1985
Decision
62d
Days
Class 2
Risk

About This 510(k) Submission

K852484 is an FDA 510(k) clearance for the PLASTINEX, a Test, Time, Prothrombin (Class II — Special Controls, product code GJS), submitted by Bio/Data Corp. (Hatboro, US). The FDA issued a Cleared decision on August 12, 1985, 62 days after receiving the submission on June 11, 1985. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7750.

Submission Details

510(k) Number K852484 FDA.gov
FDA Decision Cleared SESE
Date Received June 11, 1985
Decision Date August 12, 1985
Days to Decision 62 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GJS — Test, Time, Prothrombin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7750