Helena Biostrip a

FDA 510(k) K830978 · Helena Laboratories

Substantially Equivalent

510(k) numberK830978

Submission

Device name
Helena Biostrip a
Applicant
Helena Laboratories
Mchenry, IL, US
Received
March 29, 1983
Decision date
May 13, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
JMA – Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Device class
Class I (low risk)
Regulation
21 CFR 862.1095
Specialty
Clinical Chemistry

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K931523Quantimetrix C-Clear(Tm)JMA · Traditional Quantimetrix Corp.06/25/1993SE
K822709Uritest 9, Inlab Reagent Strips UrinalyJMA · Traditional Laprol Scientific, Inc.01/28/1983SE

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Questions and answers

When was Helena Biostrip a cleared by the FDA?

Helena Biostrip a (K830978) received a 510(k) decision of Substantially Equivalent on May 13, 1983, 45 days after the submission was received.

What is the product code of K830978?

The FDA product code is JMA – Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric), a Class I (low risk) device regulated under 21 CFR 862.1095.