N Latex Ferritin
FDA 510(k) K993273 · Dade Behring, Inc.
510(k) numberK993273
Submission
- Device name
- N Latex Ferritin
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- September 30, 1999
- Decision date
- November 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DBF – Ferritin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5340
- Specialty
- Immunology
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Questions and answers
When was N Latex Ferritin cleared by the FDA?
N Latex Ferritin (K993273) received a 510(k) decision of Substantially Equivalent on November 23, 1999, 54 days after the submission was received.
What is the product code of K993273?
The FDA product code is DBF – Ferritin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5340.