Para-Pak Clean Vial
FDA 510(k) K792710 · Meridian Diagnostics, Inc.
510(k) numberK792710
Submission
- Device name
- Para-Pak Clean Vial
- Applicant
- Meridian Diagnostics, Inc.
Mchenry, IL, US - Received
- December 27, 1979
- Decision date
- January 28, 1980
- 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 |
| K792156 | Lancer Specimen ContainerFMH · Traditional | Sherwood Medical Co. | 12/10/1979SE |
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| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
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Questions and answers
When was Para-Pak Clean Vial cleared by the FDA?
Para-Pak Clean Vial (K792710) received a 510(k) decision of Substantially Equivalent on January 28, 1980, 32 days after the submission was received.
What is the product code of K792710?
The FDA product code is FMH – Container, Specimen, Sterile, a Class I (low risk) device regulated under 21 CFR 864.3250.