Cleared Traditional

K051012 - PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML.
(FDA 510(k) Clearance)

K051012 · Salimetrics, LLC · Chemistry

Jul 2005

Decision

89d

Days

Class 2

Risk

K051012 is an FDA 510(k) clearance for the PROGESTERONE STANDARD CALIBRATOR, ONE (1) ML OF PROGESTERONE IN A SALIVA-LIKE MATRIX AT A CONCENTRATION OF 2430 PG/ML., a Calibrator, Secondary (Class II — Special Controls, product code JIT), submitted by Salimetrics, LLC (State College, US). The FDA issued a Cleared decision on July 19, 2005, 89 days after receiving the submission on April 21, 2005. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1150.

Submission Details

510(k) Number	K051012 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 21, 2005
Decision Date	July 19, 2005
Days to Decision	89 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement