Quantimetrix C-Clear(Tm)

FDA 510(k) K931523 · Quantimetrix Corp.

Substantially Equivalent

510(k) numberK931523

Submission

Device name
Quantimetrix C-Clear(Tm)
Applicant
Quantimetrix Corp.
Hawthorne, CA, US
Received
March 26, 1993
Decision date
June 25, 1993
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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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K830978Helena Biostrip aJMA · Traditional Helena Laboratories05/13/1983SE
K822709Uritest 9, Inlab Reagent Strips UrinalyJMA · Traditional Laprol Scientific, Inc.01/28/1983SE

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Questions and answers

When was Quantimetrix C-Clear(Tm) cleared by the FDA?

Quantimetrix C-Clear(Tm) (K931523) received a 510(k) decision of Substantially Equivalent on June 25, 1993, 91 days after the submission was received.

What is the product code of K931523?

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