Cleared Traditional

THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT

K872217 · Pacific Hemostasis · Hematology
Jul 1987
Decision
52d
Days
Class 2
Risk

About This 510(k) Submission

K872217 is an FDA 510(k) clearance for the THROMBOSCREEN JOSHUA HEMOGLOBIN S SCREENING KIT, a Test, Sickle Cell (Class II — Special Controls, product code GHM), submitted by Pacific Hemostasis (Ventura, US). The FDA issued a Cleared decision on July 31, 1987, 52 days after receiving the submission on June 9, 1987. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number K872217 FDA.gov
FDA Decision Cleared SESE
Date Received June 09, 1987
Decision Date July 31, 1987
Days to Decision 52 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GHM — Test, Sickle Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.7825