Cleared Traditional

K880608 - MSI-PC
(FDA 510(k) Clearance)

K880608 · Medical Specialties, Inc. · Hematology device

Mar 1988

Decision

38d

Days

Class 2

Risk

K880608 is an FDA 510(k) clearance for the MSI-PC. This device is classified as a Control, Platelet (Class II - Special Controls, product code GJP).

Submitted by Medical Specialties, Inc. (South Plainfield, US). The FDA issued a Cleared decision on March 21, 1988, 38 days after receiving the submission on February 12, 1988.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number	K880608 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 12, 1988
Decision Date	March 21, 1988
Days to Decision	38 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—