Cascade 480
FDA 510(k) K921363 · Helena Laboratories
510(k) numberK921363
Submission
- Device name
- Cascade 480
- Applicant
- Helena Laboratories
Beaumont, TX, US - Received
- March 20, 1992
- Decision date
- June 9, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- GKP – Instrument, Coagulation, Automated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.5400
- Specialty
- Hematology
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Questions and answers
When was Cascade 480 cleared by the FDA?
Cascade 480 (K921363) received a 510(k) decision of Substantially Equivalent on June 9, 1992, 81 days after the submission was received.
What is the product code of K921363?
The FDA product code is GKP – Instrument, Coagulation, Automated, a Class II (moderate risk) device regulated under 21 CFR 864.5400.