Dupont Aca Fibrin Degradation Prod Clotting Tube
FDA 510(k) K852519 · E.I. Dupont DE Nemours & Co., Inc.
510(k) numberK852519
Submission
- Device name
- Dupont Aca Fibrin Degradation Prod Clotting Tube
- Applicant
- E.I. Dupont DE Nemours & Co., Inc.
Wilmington, DE, US - Received
- June 17, 1985
- Decision date
- August 12, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JCO – Bothrops Atrox Reagent
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 864.8100
- Specialty
- Hematology
Other 510(k)s with product code JCO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K955115 | Venom Tiem ReagentJCO · Traditional | Medical Diagnostic Technologies, Inc. | 04/03/1996SE |
| K932787 | Batroxobin ReagentJCO · Traditional | Behring Diagnostics, Inc. | 11/29/1993SE |
| K896033 | FDP Collection TubesJCO · Traditional | Medical Diagnostic Technologies, Inc. | 10/27/1989SE |
| K843207 | Reptilase -PcJCO · Traditional | Bio/Data Corp. | 10/23/1984SE |
| K840210 | Reptilase-R HA35JCO · Traditional | Wellcome Diagnostics | 04/23/1984SE |
| K780355 | AtroxinJCO · Traditional | Sigma Chemical Co. | 04/18/1978SE |
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Questions and answers
When was Dupont Aca Fibrin Degradation Prod Clotting Tube cleared by the FDA?
Dupont Aca Fibrin Degradation Prod Clotting Tube (K852519) received a 510(k) decision of Substantially Equivalent on August 12, 1985, 56 days after the submission was received.
What is the product code of K852519?
The FDA product code is JCO – Bothrops Atrox Reagent, a Class II (moderate risk) device regulated under 21 CFR 864.8100.