Gen. Diag. Chromostrate Plasminogen Assay
FDA 510(k) K850410 · Warner-Lambert Co.
510(k) numberK850410
Submission
- Device name
- Gen. Diag. Chromostrate Plasminogen Assay
- Applicant
- Warner-Lambert Co.
Morris Plains, NJ, US - Received
- February 4, 1985
- Decision date
- May 8, 1985
- 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 |
| K854572 | Coatest PlasminogenDDX · Traditional | Kabivitrum, Inc. | 02/26/1986SE |
| 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 |
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| K850412 | Gen. Diag. Chromostrate Antithrombin III AssayJBQ · Traditional | 05/08/1985SE |
Questions and answers
When was Gen. Diag. Chromostrate Plasminogen Assay cleared by the FDA?
Gen. Diag. Chromostrate Plasminogen Assay (K850410) received a 510(k) decision of Substantially Equivalent on May 8, 1985, 93 days after the submission was received.
What is the product code of K850410?
The FDA product code is DDX – Plasminogen, Antigen, Antiserum, Control, a Class I (low risk) device regulated under 21 CFR 866.5715.