N Latex STFR Reagent
FDA 510(k) K991157 · Dade Behring, Inc.
510(k) numberK991157
Submission
- Device name
- N Latex STFR Reagent
- Applicant
- Dade Behring, Inc.
P.O. Box 6101, Newark, DE, US - Received
- April 7, 1999
- Decision date
- August 2, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DDG – Transferrin, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5880
- Specialty
- Immunology
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Questions and answers
When was N Latex STFR Reagent cleared by the FDA?
N Latex STFR Reagent (K991157) received a 510(k) decision of Substantially Equivalent on August 2, 1999, 117 days after the submission was received.
What is the product code of K991157?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.