Cleared Traditional

SPUNCRIT (MODEL DRC-40)

K961803 · Micro Diagnostics Corp. · Hematology

Jul 1996

Decision

57d

Days

Class 2

Risk

About This 510(k) Submission

K961803 is an FDA 510(k) clearance for the SPUNCRIT (MODEL DRC-40), a Centrifuge, Hematocrit (Class II — Special Controls, product code GKG), submitted by Micro Diagnostics Corp. (Bethlehem, US). The FDA issued a Cleared decision on July 5, 1996, 57 days after receiving the submission on May 9, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K961803 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 09, 1996
Decision Date	July 05, 1996
Days to Decision	57 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF