Dade Intl., Inc.; Premarket Approval of the acaRegister plus PSA Test Kit, acaRegister plus PSA Calibrator, and acaRegister plus PSA Control

الملخص

The Food and Drug Administration (FDA) is announcing its approval of the application by Dade Intl., Inc., Newark, DE, for premarket approval, under the Federal Food, Drug, and Cosmetic Act (the act), of the aca plus PSA Test Kit, aca plus PSA Calibrator, and aca plus PSA Control. FDA's Center for Devices and Radiological Health (CDRH) notified the applicant, by letter of September 9, 1996, of the approval of the application.