Boehringer Mannheim Tina-Quant Transferrin Assay
FDA 510(k) K933589 · Boehringer Mannheim Corp.
510(k) numberK933589
Submission
- Device name
- Boehringer Mannheim Tina-Quant Transferrin Assay
- Applicant
- Boehringer Mannheim Corp.
Indianapolis, IN, US - Received
- July 26, 1993
- Decision date
- November 3, 1993
- 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 Boehringer Mannheim Tina-Quant Transferrin Assay cleared by the FDA?
Boehringer Mannheim Tina-Quant Transferrin Assay (K933589) received a 510(k) decision of Substantially Equivalent on November 3, 1993, 100 days after the submission was received.
What is the product code of K933589?
The FDA product code is DDG – Transferrin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5880.