Cleared Traditional

AUTOMATED SLIDE SPINNER

K771898 · Dynatech Cryomedical Co. · Hematology
Oct 1977
Decision
12d
Days
Class 1
Risk

About This 510(k) Submission

K771898 is an FDA 510(k) clearance for the AUTOMATED SLIDE SPINNER, a Spinner, Slide, Automated (Class I — General Controls, product code GKJ), submitted by Dynatech Cryomedical Co. (Mchenry, US). The FDA issued a Cleared decision on October 18, 1977, 12 days after receiving the submission on October 6, 1977. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5850.

Submission Details

510(k) Number K771898 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1977
Decision Date October 18, 1977
Days to Decision 12 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GKJ — Spinner, Slide, Automated
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.5850