Cup, Disposable Specimen
FDA 510(k) K760496 · Landmark Plastics
510(k) numberK760496
Submission
- Device name
- Cup, Disposable Specimen
- Applicant
- Landmark Plastics
Mchenry, IL, US - Received
- August 23, 1976
- Decision date
- November 12, 1976
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code FMH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K900983 | Tri-Tech Urine Specimen KitFMH · Traditional | Tri-Tech, Inc. | 09/17/1990SE |
| K823763 | Various-Specimen CollectorsFMH · Traditional | Cordis Corp. | 01/19/1983SE |
| K820180 | Calculi Filter CupFMH · Traditional | Omnimedical | 02/05/1982SE |
| K812933 | Lancer Specimen ContainerFMH · Traditional | Sherwood Medical Co. | 11/06/1981SE |
| K802340 | Specimen SetFMH · Traditional | American Pharmaseal Div. Ahsc | 10/10/1980SE |
| K802002 | Urine Specimen Container #'S 1013-1016FMH · Traditional | Pollak (Intl.), Ltd. | 09/09/1980SE |
| K800947 | Midstream Collection KitFMH · Traditional | Sage Products, Inc. | 05/30/1980SE |
| K800309 | Specimen Collection PanFMH · Traditional | Sage Products, Inc. | 02/26/1980SE |
| K800233 | Abco Midstream Urine Collection SetFMH · Traditional | Abco Dealers, Inc. | 02/26/1980SE |
| K792710 | Para-Pak Clean VialFMH · Traditional | Meridian Diagnostics, Inc. | 01/28/1980SE |
More from Meridian Diagnostics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K760552 | Thermometer Stand and Dust CoverFLK · Traditional | 11/12/1976SE |
| K760548 | Carafe and Liner · Traditional | 11/12/1976SE |
| K760517 | Cup, Disposable MedicineKYX · Traditional | 11/12/1976SE |
| K760497 | Tray, ServiceLRP · Traditional | 11/12/1976SE |
| K760495 | Basin, Rectangular WashFNY · Traditional | 11/12/1976SE |
| K760494 | Basin, Round WashFNY · Traditional | 11/12/1976SE |
| K760493 | Dish, Soap · Traditional | 11/12/1976SE |
| K760492 | Basin, Large or SmallFNY · Traditional | 11/12/1976SE |
| K760490 | Bedpan, General Medical Medi-PakFOB · Traditional | 11/12/1976SE |
| K760491 | Tumbler, General Medical Medi-PakLDR · Traditional | 09/15/1976SE |
Questions and answers
When was Cup, Disposable Specimen cleared by the FDA?
Cup, Disposable Specimen (K760496) received a 510(k) decision of Substantially Equivalent on November 12, 1976, 81 days after the submission was received.
What is the product code of K760496?
The FDA product code is FMH – Container, Specimen, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.