Cleared Traditional

RED BLOOD CELL COUNT & HEMATOCRIT CNTL

K801267 · Bioscientific · Hematology
Jul 1980
Decision
47d
Days
Class 2
Risk

About This 510(k) Submission

K801267 is an FDA 510(k) clearance for the RED BLOOD CELL COUNT & HEMATOCRIT CNTL, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Bioscientific (Mchenry, US). The FDA issued a Cleared decision on July 14, 1980, 47 days after receiving the submission on May 28, 1980. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K801267 FDA.gov
FDA Decision Cleared SESE
Date Received May 28, 1980
Decision Date July 14, 1980
Days to Decision 47 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625