VENTANA CD30 (Ber-H2) RxDx Assay
FDA 510(k) K172471 · Ventana Medical Systems, Inc.
510(k) numberK172471
Submission
- Device name
- VENTANA CD30 (Ber-H2) RxDx Assay
- Applicant
- Ventana Medical Systems, Inc.
Tucson, AZ, US - Received
- August 15, 2017
- Decision date
- May 8, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DEH – Lambda, Antigen, Antiserum, Control
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 866.5550
- Specialty
- Immunology
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Questions and answers
When was VENTANA CD30 (Ber-H2) RxDx Assay cleared by the FDA?
VENTANA CD30 (Ber-H2) RxDx Assay (K172471) received a 510(k) decision of Substantially Equivalent on May 8, 2018, 266 days after the submission was received.
What is the product code of K172471?
The FDA product code is DEH – Lambda, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5550.