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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calibrator, Secondary
510(k) Number K051012
Device Name PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
Applicant
Salimetrics, LLC
101 Innovation Blvd., Suite 302
State College,  PA  16803
Applicant Contact VIRGINIA MCKAY MCKAY
Correspondent
Salimetrics, LLC
101 Innovation Blvd., Suite 302
State College,  PA  16803
Correspondent Contact VIRGINIA MCKAY MCKAY
Regulation Number862.1150
Classification Product Code
JIT  
Subsequent Product Code
JJY  
Date Received04/21/2005
Decision Date 07/19/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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