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510(k) K884750

Device
GROUP A STREP, BETA-STREP
Applicant
AMPCOR, INC.
510(k) number
K884750
Product code
GTZ  
Decision
Substantially Equivalent (SESE)
Decision date
1988-12-22
Date received
1988-11-14
Regulation
866.3740
Classification name
Antisera, All Groups, Streptococcus Spp.
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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