Para-Pak Pva
FDA 510(k) K792714 · Meridian Diagnostics, Inc.
510(k) numberK792714
Submission
- Device name
- Para-Pak Pva
- Applicant
- Meridian Diagnostics, Inc.
Mchenry, IL, US - Received
- December 27, 1979
- Decision date
- January 24, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code IFQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K792654 | Culturette Brand-Pva/Formalin KitIFQ · Traditional | Marion Laboratories, Inc. | 01/24/1980SE |
More from Marion Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K993914 | Premier Toxins A&B, Model 616096LLH · Special | 12/10/1999SE |
| K990263 | Immunocard Stat! E. Coli O157:H7GMZ · Traditional | 08/09/1999SE |
| K984346 | Premier Type Specific HSV-2 Igg Elisa TestLGC · Traditional | 06/25/1999SE |
| K984343 | Premier Type Specific HSV-1 Igg Elisa TestMXJ · Traditional | 06/25/1999SE |
| K983255 | Modification to: Premier Platinum HpsaLYR · Traditional | 12/17/1998SE |
| K982764 | Premier CryptosporidiumMHJ · Traditional | 12/03/1998SE |
| K982711 | Premier GiardiaMHI · Traditional | 11/25/1998SE |
| K980076 | Premier Platinum HpsaLYR · Traditional | 05/12/1998SE |
| K980077 | Para-Pak SpinconLKS · Traditional | 04/02/1998SE |
| K971585 | Immunocard Stat! RotavirusLIQ · Traditional | 08/20/1997SE |
Questions and answers
When was Para-Pak Pva cleared by the FDA?
Para-Pak Pva (K792714) received a 510(k) decision of Substantially Equivalent on January 24, 1980, 28 days after the submission was received.
What is the product code of K792714?
The FDA product code is IFQ – Formulations, Mercuric Chloride For Tissue, a Class I (low risk) device regulated under 21 CFR 864.4010.