Uritest 9, Inlab Reagent Strips Urinaly

FDA 510(k) K822709 · Laprol Scientific, Inc.

Substantially Equivalent

510(k) numberK822709

Submission

Device name
Uritest 9, Inlab Reagent Strips Urinaly
Applicant
Laprol Scientific, Inc.
Mchenry, IL, US
Received
September 7, 1982
Decision date
January 28, 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

Other 510(k)s with product code JMA

510(k)DeviceApplicantDecision
K931523Quantimetrix C-Clear(Tm)JMA · Traditional Quantimetrix Corp.06/25/1993SE
K830978Helena Biostrip aJMA · Traditional Helena Laboratories05/13/1983SE

More from Helena Laboratories

510(k)DeviceDecision
K831498Uri-Test 3, Inlab Reagent Strips-UrinalJIL · Traditional 06/22/1983SE
K831499Glucose 3, Inlab Reagent Strips-UrinalyJIN · Traditional 06/17/1983SE

Questions and answers

When was Uritest 9, Inlab Reagent Strips Urinaly cleared by the FDA?

Uritest 9, Inlab Reagent Strips Urinaly (K822709) received a 510(k) decision of Substantially Equivalent on January 28, 1983, 143 days after the submission was received.

What is the product code of K822709?

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