Cleared Traditional

WINPETTE

K871076 · Ulster Scientific, Inc. · Hematology
Mar 1987
Decision
5d
Days
Class 1
Risk

About This 510(k) Submission

K871076 is an FDA 510(k) clearance for the WINPETTE, a Test, Erythrocyte Sedimentation Rate (Class I — General Controls, product code JPH), submitted by Ulster Scientific, Inc. (Highland, US). The FDA issued a Cleared decision on March 23, 1987, 5 days after receiving the submission on March 18, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6700.

Submission Details

510(k) Number K871076 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1987
Decision Date March 23, 1987
Days to Decision 5 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code JPH — Test, Erythrocyte Sedimentation Rate
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.6700