The DPC Monoclonal Eia Total Ige Kit
FDA 510(k) K852878 · Diagnostic Products Corp.
510(k) numberK852878
Submission
- Device name
- The DPC Monoclonal Eia Total Ige Kit
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- July 9, 1985
- Decision date
- August 28, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 The DPC Monoclonal Eia Total Ige Kit cleared by the FDA?
The DPC Monoclonal Eia Total Ige Kit (K852878) received a 510(k) decision of Substantially Equivalent on August 28, 1985, 50 days after the submission was received.
What is the product code of K852878?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.