Cleared Traditional

HELENA BIOSTRIP A

K830978 · Helena Laboratories · Chemistry

May 1983

Decision

45d

Days

Class 1

Risk

About This 510(k) Submission

K830978 is an FDA 510(k) clearance for the HELENA BIOSTRIP A, a Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric) (Class I — General Controls, product code JMA), submitted by Helena Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 13, 1983, 45 days after receiving the submission on March 29, 1983. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1095.

Submission Details

510(k) Number	K830978 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 29, 1983
Decision Date	May 13, 1983
Days to Decision	45 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JMA — Acid, Ascorbic, 2,4-dinitrophenylhydrazine (spectrophotometric)
Device Class	Class I — General Controls
CFR Regulation	21 CFR 862.1095