Alumina Silica-Activated Partial Throm
FDA 510(k) K820835 · Hyland Therapeutic Div., Travenol Laboratories
510(k) numberK820835
Submission
- Device name
- Alumina Silica-Activated Partial Throm
- Applicant
- Hyland Therapeutic Div., Travenol Laboratories
Mchenry, IL, US - Received
- March 26, 1982
- Decision date
- April 26, 1982
- 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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| K992712 | Sigma Diagnostics Alexin LS, Models A1219, A1334GFO · Traditional | Sigma Diagnostics, Inc. | 12/06/1999SE |
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Questions and answers
When was Alumina Silica-Activated Partial Throm cleared by the FDA?
Alumina Silica-Activated Partial Throm (K820835) received a 510(k) decision of Substantially Equivalent on April 26, 1982, 31 days after the submission was received.
What is the product code of K820835?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.