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510(k) K922723

Device
TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL
Applicant
SIMPLICITY DIAGNOSTICS, INC.
510(k) number
K922723
Product code
GTQ  
Decision
Substantially Equivalent (SESE)
Decision date
1992-09-18
Date received
1992-06-05
Regulation
866.3720
Classification name
Antistreptolysin - Titer/streptolysin O Reagent
Medical specialty
Microbiology
Review panel
Microbiology
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
JEFFREY FLEISHMAN
Address
P.O. Box 730 21 N. York Rd. Hatboro PA US 19040 19040

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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