Cleared Traditional

IMMUCHEM COVALENT-COAT RIA KIT

K830962 · Immuchem Corp. · Chemistry

May 1983

Decision

37d

Days

Class 2

Risk

About This 510(k) Submission

K830962 is an FDA 510(k) clearance for the IMMUCHEM COVALENT-COAT RIA KIT, a Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep. (Class II — Special Controls, product code DPO), submitted by Immuchem Corp. (Mchenry, US). The FDA issued a Cleared decision on May 4, 1983, 37 days after receiving the submission on March 28, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.3320.

Submission Details

510(k) Number	K830962 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 28, 1983
Decision Date	May 04, 1983
Days to Decision	37 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	DPO — Radioimmunoassay, Digoxin (125-i), Rabbit Antibody, Coated Tube Sep.
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.3320