Cleared Traditional

ALBP

K981814 · Abbott Laboratories · Chemistry
Jul 1998
Decision
61d
Days
Class 2
Risk

About This 510(k) Submission

K981814 is an FDA 510(k) clearance for the ALBP, a Bromcresol Purple Dye-binding, Albumin (Class II — Special Controls, product code CJW), submitted by Abbott Laboratories (Irving, US). The FDA issued a Cleared decision on July 22, 1998, 61 days after receiving the submission on May 22, 1998. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1035.

Submission Details

510(k) Number K981814 FDA.gov
FDA Decision Cleared SESE
Date Received May 22, 1998
Decision Date July 22, 1998
Days to Decision 61 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CJW — Bromcresol Purple Dye-binding, Albumin
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1035

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