Para-Pak Plus
FDA 510(k) K931770 · Meridian Diagnostics, Inc.
510(k) numberK931770
Submission
- Device name
- Para-Pak Plus
- Applicant
- Meridian Diagnostics, Inc.
Cincinnati, OH, US - Received
- April 9, 1993
- Decision date
- June 15, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- LIO – Device, Specimen Collection
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 866.2900
- Specialty
- Microbiology
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| K984343 | Premier Type Specific HSV-1 Igg Elisa TestMXJ · Traditional | 06/25/1999SE |
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| 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 Plus cleared by the FDA?
Para-Pak Plus (K931770) received a 510(k) decision of Substantially Equivalent on June 15, 1993, 67 days after the submission was received.
What is the product code of K931770?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.