TINA-QUANT HAPTOGLOBIN

Haptoglobin, Antigen, Antiserum, Control

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Tina-quant Haptoglobin.

Pre-market Notification Details

Device IDK972639
510k NumberK972639
Device Name:TINA-QUANT HAPTOGLOBIN
ClassificationHaptoglobin, Antigen, Antiserum, Control
Applicant BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord,  CA  94520
ContactMary Koning
CorrespondentMary Koning
BOEHRINGER MANNHEIM CORP. 2380A BISSO LN. Concord,  CA  94520
Product CodeDAD  
CFR Regulation Number866.5460 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-07-15
Decision Date1998-01-09
Summary:summary

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