Aca Activated Partial Thromboplastin Time Analytic
FDA 510(k) K851126 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK851126
Submission
- Device name
- Aca Activated Partial Thromboplastin Time Analytic
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- March 19, 1985
- Decision date
- May 29, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- GGW – Test, Time, Partial Thromboplastin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7925
- Specialty
- Hematology
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Questions and answers
When was Aca Activated Partial Thromboplastin Time Analytic cleared by the FDA?
Aca Activated Partial Thromboplastin Time Analytic (K851126) received a 510(k) decision of Substantially Equivalent on May 29, 1985, 71 days after the submission was received.
What is the product code of K851126?
The FDA product code is GGW – Test, Time, Partial Thromboplastin, a Class II (moderate risk) device regulated under 21 CFR 864.7925.