Cleared Traditional

CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL

K982172 · Coulter Corp. · Hematology

Sep 1998

Decision

97d

Days

Class 2

Risk

About This 510(k) Submission

K982172 is an FDA 510(k) clearance for the CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on September 24, 1998, 97 days after receiving the submission on June 19, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number	K982172 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 19, 1998
Decision Date	September 24, 1998
Days to Decision	97 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF