N Latex Ige Kit (Immunoglobulin E Reagents)
FDA 510(k) K890530 · Behring Diagnostics, Inc.
510(k) numberK890530
Submission
- Device name
- N Latex Ige Kit (Immunoglobulin E Reagents)
- Applicant
- Behring Diagnostics, Inc.
Somerville, NJ, US - Received
- February 2, 1989
- Decision date
- March 27, 1989
- 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 N Latex Ige Kit (Immunoglobulin E Reagents) cleared by the FDA?
N Latex Ige Kit (Immunoglobulin E Reagents) (K890530) received a 510(k) decision of Substantially Equivalent on March 27, 1989, 53 days after the submission was received.
What is the product code of K890530?
The FDA product code is DGC – Ige, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5510.