Cleared Traditional

SPQ(TM) TEST SYSTEM FOR PREALBUMIN

K884297 · Atlantic Antibodies · Immunology
Nov 1988
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K884297 is an FDA 510(k) clearance for the SPQ(TM) TEST SYSTEM FOR PREALBUMIN, a Prealbumin, Antigen, Antiserum, Control (Class I — General Controls, product code JZJ), submitted by Atlantic Antibodies (Scarborough, US). The FDA issued a Cleared decision on November 2, 1988, 21 days after receiving the submission on October 12, 1988. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number K884297 FDA.gov
FDA Decision Cleared SESE
Date Received October 12, 1988
Decision Date November 02, 1988
Days to Decision 21 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code JZJ — Prealbumin, Antigen, Antiserum, Control
Device Class Class I — General Controls
CFR Regulation 21 CFR 866.5060

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