Coatest Plasminogen
FDA 510(k) K854572 · Kabivitrum, Inc.
510(k) numberK854572
Submission
- Device name
- Coatest Plasminogen
- Applicant
- Kabivitrum, Inc.
Alameda, CA, US - Received
- November 14, 1985
- Decision date
- February 26, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DDX – Plasminogen, Antigen, Antiserum, Control
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.5715
- Specialty
- Immunology
Other 510(k)s with product code DDX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K941346 | Plasminogen Rid Test KitDDX · Traditional | The Binding Site, Ltd. | 09/09/1994SE |
| K884766 | Berichrom(R) PlasminogenDDX · Traditional | Behring Diagnostics, Inc. | 01/04/1989SE |
| K864212 | Il Test 97573-15, Plasminogen AssayDDX · Traditional | Instrumentation Laboratory CO | 12/04/1986SE |
| K850410 | Gen. Diag. Chromostrate Plasminogen AssayDDX · Traditional | Warner-Lambert Co. | 05/08/1985SE |
| K832591 | Diacrom *PlgDDX · Traditional | Wellcome Diagnostics | 11/21/1983SE |
| K812625 | Aca Plasminogen Test PackDDX · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 09/29/1981SE |
| K811777 | Helena Plasminogen Quiplate ProcedureDDX · Traditional | Helena Laboratories | 07/02/1981SE |
| K781478 | Plasminogen AssayDDX · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 11/15/1978SE |
| K772085 | Las-R Human Plasminogen TestDDX · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 01/24/1978SE |
More from Hyland Therapeutic Div., Travenol Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K884058 | Coatest Protein CGGP · Traditional | 12/13/1988SE |
| K844664 | The I.V. BagKPE · Traditional | 05/06/1985SE |
| K833892 | Coatest Factor ViiiGGP · Traditional | 01/30/1984SE |
| K833891 | Coatest HeparinKFF · Traditional | 01/30/1984SE |
| K833890 | Coatest AntiplasminLGP · Traditional | 01/30/1984SE |
| K832114 | Coatest Factor XGGP · Traditional | 08/26/1983SE |
| K812829 | Coatest AntithrombinJBQ · Traditional | 12/30/1981SE |
Questions and answers
When was Coatest Plasminogen cleared by the FDA?
Coatest Plasminogen (K854572) received a 510(k) decision of Substantially Equivalent on February 26, 1986, 104 days after the submission was received.
What is the product code of K854572?
The FDA product code is DDX – Plasminogen, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5715.