Cleared Traditional

K885324 - HEMA(PRO)TEC(TION)
(FDA 510(k) Clearance)

K885324 · Medical Products Search, Inc. · Hematology

Feb 1989

Decision

51d

Days

Class 1

Risk

K885324 is an FDA 510(k) clearance for the HEMA(PRO)TEC(TION). This device is classified as a Tube, Collection, Capillary Blood (Class I — General Controls, product code GIO).

Submitted by Medical Products Search, Inc. (Winston-Salem, US). The FDA issued a Cleared decision on February 17, 1989, 51 days after receiving the submission on December 28, 1988.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6150.

Submission Details

510(k) Number	K885324 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 28, 1988
Decision Date	February 17, 1989
Days to Decision	51 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	—