Cleared Traditional

DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB

K831957 · Kent Laboratories, Inc. · Chemistry
Jul 1983
Decision
31d
Days
Class 2
Risk

About This 510(k) Submission

K831957 is an FDA 510(k) clearance for the DETERM. SIZE 72 RADIAL HUMAN HAPTOGLOB, a Haptoglobin, Antigen, Antiserum, Control (Class II — Special Controls, product code DAD), submitted by Kent Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 18, 1983, 31 days after receiving the submission on June 17, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 866.5460.

Submission Details

510(k) Number K831957 FDA.gov
FDA Decision Cleared SESE
Date Received June 17, 1983
Decision Date July 18, 1983
Days to Decision 31 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code DAD — Haptoglobin, Antigen, Antiserum, Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 866.5460

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