Cleared Traditional

IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S

K980331 · More Diagnostics · Toxicology
Mar 1998
Decision
47d
Days
Class 1
Risk

About This 510(k) Submission

K980331 is an FDA 510(k) clearance for the IMMUNOSUPPRESSANT (WHOLE BLOOD) CONTROL, LEVEL 1 250-1, IMMUNOSUPPRESSANT (WHOLE BLOOS) CONTROL, LEVEL 2, 250-2, IMMUN\S, a Drug Mixture Control Materials (Class I — General Controls, product code DIF), submitted by More Diagnostics (Los Osos, US). The FDA issued a Cleared decision on March 16, 1998, 47 days after receiving the submission on January 28, 1998. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3280.

Submission Details

510(k) Number K980331 FDA.gov
FDA Decision Cleared SESE
Date Received January 28, 1998
Decision Date March 16, 1998
Days to Decision 47 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Statement

Device Classification

Product Code DIF — Drug Mixture Control Materials
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.3280

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