Cleared Traditional

K761250 - SIMPLATE
(FDA 510(k) Clearance)

K761250 · General Diagnostics · Hematology

Mar 1977

Decision

78d

Days

Class 2

Risk

K761250 is an FDA 510(k) clearance for the SIMPLATE. This device is classified as a Device, Bleeding Time (Class II — Special Controls, product code JCA).

Submitted by General Diagnostics (Mchenry, US). The FDA issued a Cleared decision on March 1, 1977, 78 days after receiving the submission on December 13, 1976.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6100.

Submission Details

510(k) Number	K761250 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 13, 1976
Decision Date	March 01, 1977
Days to Decision	78 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—