Mid-Stream Urine Collection Sets
FDA 510(k) K840709 · Concord Laboratories, Inc.
510(k) numberK840709
Submission
- Device name
- Mid-Stream Urine Collection Sets
- Applicant
- Concord Laboratories, Inc.
Mchenry, IL, US - Received
- February 17, 1984
- Decision date
- April 3, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
No product code recorded.
More from Concord Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K883840 | Dri-Vent Arterial Blood Sampling KitLKB · Traditional | 05/16/1989SESD |
| K871825 | Meconium Suction CatheterBSY · Traditional | 06/29/1987SE |
| K864535 | Tracheobronchial Suction Catheter, Cat. No. 6110BSY · Traditional | 01/06/1987SE |
| K862039 | Concord Care Tray · Traditional | 07/03/1986SESD |
| K854601 | Spring Guide Catheter Anesthesia Conduction CathBSO · Traditional | 01/10/1986SE |
| K854327 | Subcutaneous Tunneling Needles & HandlesGCB · Traditional | 11/13/1985SE |
| K851134 | Regional Anesthesia TraysCAZ · Traditional | 07/15/1985SESD |
| K842095 | Epidural TraysCAZ · Traditional | 07/03/1984SE |
| K841486 | Arterial Blood Sampling KitsCBT · Traditional | 05/23/1984SE |
| K840987 | Vaporized HeparinCBT · Traditional | 04/05/1984SE |
Questions and answers
When was Mid-Stream Urine Collection Sets cleared by the FDA?
Mid-Stream Urine Collection Sets (K840709) received a 510(k) decision of Substantially Equivalent on April 3, 1984, 46 days after the submission was received.