Cleared Traditional

ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01

K063232 · Biokit, S.A. · Chemistry
Jun 2007
Decision
237d
Days
Class 2
Risk

About This 510(k) Submission

K063232 is an FDA 510(k) clearance for the ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01, a Radioimmunoassay, Parathyroid Hormone (Class II — Special Controls, product code CEW), submitted by Biokit, S.A. (Barcelona, ES). The FDA issued a Cleared decision on June 19, 2007, 237 days after receiving the submission on October 25, 2006. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1545.

Submission Details

510(k) Number K063232 FDA.gov
FDA Decision Cleared SESE
Date Received October 25, 2006
Decision Date June 19, 2007
Days to Decision 237 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code CEW — Radioimmunoassay, Parathyroid Hormone
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1545

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