Cleared Traditional

UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM

K875354 · Ulster Scientific, Inc. · Hematology
Feb 1988
Decision
48d
Days
Class 2
Risk

About This 510(k) Submission

K875354 is an FDA 510(k) clearance for the UNISTEP CAPILLARY BLOOD COLLECTION SYSTEM, a Assay, Glycosylated Hemoglobin (Class II — Special Controls, product code LCP), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on February 17, 1988, 48 days after receiving the submission on December 31, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7470.

Submission Details

510(k) Number K875354 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1987
Decision Date February 17, 1988
Days to Decision 48 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code LCP — Assay, Glycosylated Hemoglobin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7470

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