510(k) K013857

Device
AIMSTEP PREGNANCY
Applicant
Germaine Laboratories, Inc.
510(k) number
K013857
Product code
DHA
Decision
Substantially Equivalent (SESE)
Decision date
2002-01-22
Date received
2001-11-21
Regulation
862.1155
Classification name
System, Test, Human Chorionic Gonadotropin
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
MARTIN O'CONNOER
Address
4139 Gardendale Center, Suite 101 San Antonio TX US 78229 78229

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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