Cleared Traditional

WESTERGREN DISPETTE FOR ESR

K831195 · Ulster Scientific, Inc. · Hematology
May 1983
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K831195 is an FDA 510(k) clearance for the WESTERGREN DISPETTE FOR ESR, a Test, Erythrocyte Sedimentation Rate (Class I — General Controls, product code JPH), submitted by Ulster Scientific, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1983, 27 days after receiving the submission on April 12, 1983. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6700.

Submission Details

510(k) Number K831195 FDA.gov
FDA Decision Cleared SESE
Date Received April 12, 1983
Decision Date May 09, 1983
Days to Decision 27 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