Cleared Traditional

TINA-QUANT PREALBUMIN

K972638 · Boehringer Mannheim Corp. · Immunology
Jan 1998
Decision
178d
Days
Class 1
Risk

About This 510(k) Submission

K972638 is an FDA 510(k) clearance for the TINA-QUANT PREALBUMIN, a Prealbumin, Antigen, Antiserum, Control (Class I — General Controls, product code JZJ), submitted by Boehringer Mannheim Corp. (Concord, US). The FDA issued a Cleared decision on January 9, 1998, 178 days after receiving the submission on July 15, 1997. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5060.

Submission Details

510(k) Number K972638 FDA.gov
FDA Decision Cleared SESE
Date Received July 15, 1997
Decision Date January 09, 1998
Days to Decision 178 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Summary PDF

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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