Cleared Traditional

INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999

K033603 · Beckman Coulter, Inc. · Chemistry

Dec 2003

Decision

32d

Days

Class 2

Risk

About This 510(k) Submission

K033603 is an FDA 510(k) clearance for the INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999, a Radioassay, Intrinsic Factor Blocking Antibody (Class II — Special Controls, product code LIG), submitted by Beckman Coulter, Inc. (Chaska, US). The FDA issued a Cleared decision on December 19, 2003, 32 days after receiving the submission on November 17, 2003. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number	K033603 FDA.gov
FDA Decision	Cleared SESE
Date Received	November 17, 2003
Decision Date	December 19, 2003
Days to Decision	32 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Summary PDF