Cleared Traditional

HEMATOLOGY DATA MANAGEMENT SYS

K821534 · Biovation, Inc. · Hematology
Jun 1982
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K821534 is an FDA 510(k) clearance for the HEMATOLOGY DATA MANAGEMENT SYS, a Lowry (colorimetric), Total Protein (Class II — Special Controls, product code JGP), submitted by Biovation, Inc. (Walker, US). The FDA issued a Cleared decision on June 10, 1982, 17 days after receiving the submission on May 24, 1982. This device falls under the Hematology review panel. Regulated under 21 CFR 862.1635.

Submission Details

510(k) Number K821534 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1982
Decision Date June 10, 1982
Days to Decision 17 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JGP — Lowry (colorimetric), Total Protein
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1635