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510(k) K893038

Device
PROTOFLUOR Z
Applicant
HELENA LABORATORIES
510(k) number
K893038
Product code
JKJ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-11-17
Date received
1989-04-24
Regulation
862.1595
Classification name
Fluorometric Measurement, Porphyrins
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
PAT FRANKS
Address
1530 Lindbergh Dr. P.O. Box 752 Beaumont TX US 77704 77704

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code JKJ  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K871499PROTOFLUOR ZHelena Laboratories1987-08-25
K780455QUANTITATIVE DETERMINATION OF PORPHYRINSWhale Scientific, Inc.1978-07-27

Legacy Summary#

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FDA Review#

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