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510(k) K913410

Device
EMIT(R) 2000 GENTAMICIN ASSAY/CALIBRATORS
Applicant
SYVA CO.
510(k) number
K913410
Product code
DMB  
Decision
Substantially Equivalent (SESE)
Decision date
1991-09-16
Date received
1991-07-31
Regulation
862.3620
Classification name
Gas Chromatography, Methadone
Medical specialty
Toxicology
Review panel
Toxicology
Device class
2
Clearance type
Traditional
Statement or summary
Statement
Third party reviewed
No

Applicant Contact#

Contact
PAUL L ROGERS
Address
900 Arastradero Rd. P.O. Box 10058 Palo Alto CA US 94303 94303

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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