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

Radioimmunoassay, Parathyroid Hormone

BIOKIT S.A.

The following data is part of a premarket notification filed by Biokit S.a. with the FDA for Architect Intact Pth Reagents, Calibrators (a-f) And Controls (low, Medium, High), Models 8k25-20, 8k25-25, 8k25-01.

Pre-market Notification Details

• Device ID: K063232
• 510k Number: K063232
• Device Name: ARCHITECT INTACT PTH REAGENTS, CALIBRATORS (A-F) AND CONTROLS (LOW, MEDIUM, HIGH), MODELS 8K25-20, 8K25-25, 8K25-01
• Classification: Radioimmunoassay, Parathyroid Hormone
• Applicant: BIOKIT S.A. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186
• Contact: Joan Guixer
• Correspondent: Joan Guixer; BIOKIT S.A. CAN MALE LLISSA D'AMUNT Barcelona, ES 08186
• Product Code: CEW
• Subsequent Product Code: JIT
• Subsequent Product Code: JJX
• CFR Regulation Number: 862.1545 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2006-10-25
• Decision Date: 2007-06-19
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00380740136215	K063232	000