Cleared Traditional

IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6

K993251 · Diagnostic Products Corp. · Chemistry
Nov 1999
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K993251 is an FDA 510(k) clearance for the IMMULITE 2000 VITAMIN B12, MODEL L2KVB2, L2KVB6, a Radioassay, Intrinsic Factor Blocking Antibody (Class II — Special Controls, product code LIG), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on November 17, 1999, 50 days after receiving the submission on September 28, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1810.

Submission Details

510(k) Number K993251 FDA.gov
FDA Decision Cleared SESE
Date Received September 28, 1999
Decision Date November 17, 1999
Days to Decision 50 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

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