DV Test and DVV Confirm
FDA 510(k) K940490 · American Diagnostica, Inc.
510(k) numberK940490
Submission
- Device name
- DV Test and DVV Confirm
- Applicant
- American Diagnostica, Inc.
Greenwich, CT, US - Received
- February 3, 1994
- Decision date
- April 5, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GIR – Reagent, Russel Viper Venom
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.8950
- Specialty
- Hematology
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Questions and answers
When was DV Test and DVV Confirm cleared by the FDA?
DV Test and DVV Confirm (K940490) received a 510(k) decision of Substantially Equivalent on April 5, 1995, 426 days after the submission was received.
What is the product code of K940490?
The FDA product code is GIR – Reagent, Russel Viper Venom, a Class I (low risk) device regulated under 21 CFR 864.8950.