Spectrolyse Heparin (Anti-Iia)
FDA 510(k) K972209 · Medical Diagnostic Technologies, Inc.
510(k) numberK972209
Submission
- Device name
- Spectrolyse Heparin (Anti-Iia)
- Applicant
- Medical Diagnostic Technologies, Inc.
Ventura, CA, US - Received
- June 11, 1997
- Decision date
- August 12, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- KFF – Assay, Heparin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7525
- Specialty
- Hematology
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| K955115 | Venom Tiem ReagentJCO · Traditional | 04/03/1996SE |
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Questions and answers
When was Spectrolyse Heparin (Anti-Iia) cleared by the FDA?
Spectrolyse Heparin (Anti-Iia) (K972209) received a 510(k) decision of Substantially Equivalent on August 12, 1997, 62 days after the submission was received.
What is the product code of K972209?
The FDA product code is KFF – Assay, Heparin, a Class II (moderate risk) device regulated under 21 CFR 864.7525.