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510(k) K894780

Device
IMMUNO/ASO
Applicant
IMMUNOSTICS CO., INC.
510(k) number
K894780
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-10-16
Date received
1989-07-27
Regulation
866.3720
Classification name
Antistreptolysin - Titer/streptolysin O Reagent
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
KENNETH KUPITS
Address
3505 Sunset Ave. Ocean NJ US 07712 07712

FDA Registration Numbers#

Source Documents#

510(k) summary PDF not indicated by FDA

Legacy Summary#

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FDA Review#

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