Aca Prothrombin Time Analytical Test Pack
FDA 510(k) K851125 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK851125
Submission
- Device name
- Aca Prothrombin Time Analytical Test Pack
- 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
- GJS – Test, Time, Prothrombin
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.7750
- Specialty
- Hematology
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| K213426 | HemosIL ReadiPlasTinGJS · Traditional | Instrumentation Laboratory CO | 08/16/2022SE |
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Questions and answers
When was Aca Prothrombin Time Analytical Test Pack cleared by the FDA?
Aca Prothrombin Time Analytical Test Pack (K851125) 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 K851125?
The FDA product code is GJS – Test, Time, Prothrombin, a Class II (moderate risk) device regulated under 21 CFR 864.7750.