Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade Kit
FDA 510(k) K002563 · The Binding Site, Ltd.
510(k) numberK002563
Submission
- Device name
- Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade Kit
- Applicant
- The Binding Site, Ltd.
Santa Monica, CA, US - Received
- August 17, 2000
- Decision date
- October 26, 2000
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DEH – Lambda, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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Questions and answers
When was Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade Kit cleared by the FDA?
Sheep Anti-Human Lambda Free Light Chain Immunofixation Grade Kit (K002563) received a 510(k) decision of Substantially Equivalent on October 26, 2000, 70 days after the submission was received.
What is the product code of K002563?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.