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510(k) K002128

Device
ACTIVE INHIBIN-A ELISA, MODEL DSL-10-28100
Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
510(k) number
K002128
Product code
NDR  
Decision
Substantially Equivalent (SESE)
Decision date
2000-12-05
Date received
2000-07-14
Regulation
862.1260
Classification name
Enzyme Immunoassay, Inhibin-a
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
1
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
MICHAEL (RUSTY) NICAR
Address
445 Medical Center Blvd. Webster TX US 77598 77598

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Legacy Summary#

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FDA Review#

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