Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01
FDA 510(k) K063232 · Biokit, S.A.
510(k) numberK063232
Submission
- Device name
- Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01
- Applicant
- Biokit, S.A.
Barcelona, ES - Received
- October 25, 2006
- Decision date
- June 19, 2007
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CEW – Radioimmunoassay, Parathyroid Hormone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1545
- Specialty
- Clinical Chemistry
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Questions and answers
When was Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01 cleared by the FDA?
Architect Intact PTH Reagents, Calibrators (A-F) and Controls (Low, Medium, High), Models 8K25-20, 8K25-25, 8K25-01 (K063232) received a 510(k) decision of Substantially Equivalent on June 19, 2007, 237 days after the submission was received.
What is the product code of K063232?
The FDA product code is CEW – Radioimmunoassay, Parathyroid Hormone, a Class II (moderate risk) device regulated under 21 CFR 862.1545.