Activated Partial Thromboplastin Time (Aptt)
FDA 510(k) K896545 · Sigma Chemical Co.
510(k) numberK896545
Submission
- Device name
- Activated Partial Thromboplastin Time (Aptt)
- Applicant
- Sigma Chemical Co.
St. Louis, MO, US - Received
- November 17, 1989
- Decision date
- December 1, 1989
- 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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| K933692 | Sigma CO2 Acid ReagentJFL · Traditional | 12/09/1993SE |
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Questions and answers
When was Activated Partial Thromboplastin Time (Aptt) cleared by the FDA?
Activated Partial Thromboplastin Time (Aptt) (K896545) received a 510(k) decision of Substantially Equivalent on December 1, 1989, 14 days after the submission was received.
What is the product code of K896545?
The FDA product code is GFO – Activated Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.