Cleared Traditional

SANASSAY IC TEST

K860996 · Scientific Sales Intl., Inc. · Immunology
Mar 1987
Decision
384d
Days
Class 2
Risk

About This 510(k) Submission

K860996 is an FDA 510(k) clearance for the SANASSAY IC TEST, a Complement C1q, Antigen, Antiserum, Control (Class II — Special Controls, product code DAK), submitted by Scientific Sales Intl., Inc. (Kalamazoo, US). The FDA issued a Cleared decision on March 30, 1987, 384 days after receiving the submission on March 11, 1986. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5240.

Submission Details

510(k) Number K860996 FDA.gov
FDA Decision Cleared SESE
Date Received March 11, 1986
Decision Date March 30, 1987
Days to Decision 384 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary —

Device Classification

Product Code DAK — Complement C1q, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5240

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