Cleared Traditional

TOUCH TEAR IGE MICROASSAY KIT

K991316 · Touch Scientific, Inc. · Immunology
Aug 1999
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K991316 is an FDA 510(k) clearance for the TOUCH TEAR IGE MICROASSAY KIT, a Ige, Antigen, Antiserum, Control (Class II — Special Controls, product code DGC), submitted by Touch Scientific, Inc. (Raleigh, US). The FDA issued a Cleared decision on August 9, 1999, 112 days after receiving the submission on April 19, 1999. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number K991316 FDA.gov
FDA Decision Cleared SESE
Date Received April 19, 1999
Decision Date August 09, 1999
Days to Decision 112 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary Statement

Device Classification

Product Code DGC — Ige, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5510

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