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510(k) K830978

Device
Helena Biostrip A
Applicant
HELENA LABORATORIES
510(k) number
K830978
Product code
JMA
Decision
Substantially Equivalent (SESE)
Decision date
1983-05-13
Date received
1983-03-29
Regulation
862.1095
Classification name
Acid, Ascorbic, 2,4-Dinitrophenylhydrazine (Spectrophotometric)
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Address
803 N. Front St. Suite 3 Mchenry IL US 60050 60050

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JMA#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K931523QUANTIMETRIX C-CLEAR(TM)Quantimetrix Corp.1993-06-25
K822709URITEST 9, INLAB REAGENT STRIPS URINALYLaprol Scientific, Inc.1983-01-28