Cleared Traditional

ABBOTT ARCHITECT B12

K984108 · Abbott Laboratories · Chemistry
Feb 1999
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K984108 is an FDA 510(k) clearance for the ABBOTT ARCHITECT B12, a Radioassay, Intrinsic Factor Blocking Antibody (Class II — Special Controls, product code LIG), submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 3, 1999, 78 days after receiving the submission on November 17, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K984108 FDA.gov
FDA Decision Cleared SESE
Date Received November 17, 1998
Decision Date February 03, 1999
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LIG — Radioassay, Intrinsic Factor Blocking Antibody
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1810

Similar Devices — LIG Radioassay, Intrinsic Factor Blocking Antibody

All 7
Access Intrinsic Factor Ab
K240800 · Beckman Coulter, Inc. · May 2024
IMMULISA INTRINSIC FACTOR ANTIBODY ELISA
K071346 · Immco Diagnostics, Inc. · Sep 2007
QUANTA LITE INTRINSIC FACTOR ELISA
K061841 · Inova Diagnostics, Inc. · Dec 2006
INSTRINSIC FACTOR AB, CALIBRATORS, AND QC ON THE ACCESS IMMUNOASSAY SYSTEMS, MODELS 387992, 387993, 387999
K033603 · Beckman Coulter, Inc. · Dec 2003
IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6
K993251 · Diagnostic Products Corp. · Nov 1999
IMX B12
K903218 · Abbott Laboratories · Aug 1990