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510(k) K051012

PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML. by Salimetrics, LLC — Product Code JIT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 19, 2005
Date Received
April 21, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Secondary
Device Class
Class II
Regulation Number
862.1150
Review Panel
CH
Submission Type

Other clearances by Salimetrics, LLC

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  • K011323 — HIGH SENSITIVITY CORTISOL ENZYME IMMUNOASSAY, MODEL 1-0101/1-0102 (December 17, 2001)

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