Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064
FDA 510(k) K922047 · Medix Biotech, Inc.
510(k) numberK922047
Submission
- Device name
- Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064
- Applicant
- Medix Biotech, Inc.
Foster City, CA, US - Received
- May 1, 1992
- Decision date
- August 5, 1992
- 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 Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064 cleared by the FDA?
Ige Enzyme Immunoassay Test Kit Cat.No. KIF4064 (K922047) received a 510(k) decision of Substantially Equivalent on August 5, 1992, 96 days after the submission was received.
What is the product code of K922047?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.