Cleared Traditional

K972639 - TINA-QUANT HAPTOGLOBIN
(FDA 510(k) Clearance)

K972639 · Boehringer Mannheim Corp. · Immunology

Jan 1998

Decision

178d

Days

Class 2

Risk

K972639 is an FDA 510(k) clearance for the TINA-QUANT HAPTOGLOBIN. This device is classified as a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD).

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 FDA review panel. Regulated under 21 CFR 866.5460.

Submission Details

510(k) Number	K972639 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