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510(k) K853053

Device
PRECEPT ERYTHROMYCIN
Applicant
AUSTIN BIOLOGICAL LABORATORIES
510(k) number
K853053
Product code
LTW  
Decision
Substantially Equivalent (SESE)
Decision date
1985-08-29
Date received
1985-07-19
Regulation
866.1640
Classification name
Susceptibility Test Cards, Antimicrobial
Medical specialty
Microbiology
Review panel
Microbiology
Device class
2
Clearance type
Traditional
Third party reviewed
No

Applicant Contact#

Contact
DENNIS R SCHNEIDER
Address
6620-A Manor Rd. Austin TX US 78723 78723

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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