Unifast Activated Partial Thromboplastin Time Test
FDA 510(k) K882325 · Sclavo, Inc.
510(k) numberK882325
Submission
- Device name
- Unifast Activated Partial Thromboplastin Time Test
- Applicant
- Sclavo, Inc.
Wayne, NJ, US - Received
- June 6, 1988
- Decision date
- August 25, 1988
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GFO – Activated Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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Questions and answers
When was Unifast Activated Partial Thromboplastin Time Test cleared by the FDA?
Unifast Activated Partial Thromboplastin Time Test (K882325) received a 510(k) decision of Substantially Equivalent on August 25, 1988, 80 days after the submission was received.
What is the product code of K882325?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.