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510(k) K903609

Device
SEROTONIN ENZYME IMMUNOASSAY
Applicant
IMMUNOTECH CORP.
510(k) number
K903609
Product code
CDA  
Decision
Substantially Equivalent (SESE)
Decision date
1990-10-22
Date received
1990-08-09
Regulation
862.1390
Classification name
Acid, Nitrous And Nitrosonaphthol, 5-hydroxyindole Acetic Acid/serotonin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
RICKENBERG
Address
130, Ave. Jean De Lattre De Tassigny-Bp 177, 13276 Marseil Cedex 9 (France) FR

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Other 510(k) Records For Product Code CDA  #

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K952817BIO-RAD URINARY 5-HIAA BY HPLCBio-Rad1995-08-01
K854946TDXR 5-HIAA (URINE)Abbott Laboratories1986-01-17

Legacy Summary#

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FDA Review#

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