Cleared Traditional

COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT

K891167 · Diagnostic Products Corp. · Toxicology
May 1989
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K891167 is an FDA 510(k) clearance for the COAT-A-COUNT(TM) LSD RADIOIMMUNOASSAY KIT, a Radioimmunoassay, Lsd (125-i) (Class II — Special Controls, product code DLB), submitted by Diagnostic Products Corp. (Los Angeles, US). The FDA issued a Cleared decision on May 3, 1989, 58 days after receiving the submission on March 6, 1989. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3580.

Submission Details

510(k) Number K891167 FDA.gov
FDA Decision Cleared SESE
Date Received March 06, 1989
Decision Date May 03, 1989
Days to Decision 58 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary —

Device Classification

Product Code DLB — Radioimmunoassay, Lsd (125-i)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3580

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