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510(k) K890025

Device
QUIK-DOT ANTISTREPTOLYSIN-O
Applicant
AMPCOR, INC.
510(k) number
K890025
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1989-01-31
Date received
1989-01-04
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
RAYMOND GOULD
Address
510 Heron Dr., Bldg. 306 P.O. Box 521 Bridgeport NJ US 08014 08014

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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