Kallestead Total Ige Microplate Kit
FDA 510(k) K912800 · Bio-Rad Laboratories, Inc.
510(k) numberK912800
Submission
- Device name
- Kallestead Total Ige Microplate Kit
- Applicant
- Bio-Rad Laboratories, Inc.
Chaska, MN, US - Received
- June 25, 1991
- Decision date
- July 25, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DGC – Ige, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5510
- Specialty
- Immunology
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Questions and answers
When was Kallestead Total Ige Microplate Kit cleared by the FDA?
Kallestead Total Ige Microplate Kit (K912800) received a 510(k) decision of Substantially Equivalent on July 25, 1991, 30 days after the submission was received.
What is the product code of K912800?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.