Cleared Traditional

SAS SICKLE CELL TEST

K960947 · Sa Scientific, Inc. · Hematology
Jul 1996
Decision
115d
Days
Class 2
Risk

About This 510(k) Submission

K960947 is an FDA 510(k) clearance for the SAS SICKLE CELL TEST, a Test, Sickle Cell (Class II — Special Controls, product code GHM), submitted by Sa Scientific, Inc. (San Antonio, US). The FDA issued a Cleared decision on July 1, 1996, 115 days after receiving the submission on March 8, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.7825.

Submission Details

510(k) Number K960947 FDA.gov
FDA Decision Cleared SESE
Date Received March 08, 1996
Decision Date July 01, 1996
Days to Decision 115 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

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