Nat - Nucleic Acid Transport
FDA 510(k) K003761 · Medical Packaging Corp.
510(k) numberK003761
Submission
- Device name
- Nat - Nucleic Acid Transport
- Applicant
- Medical Packaging Corp.
Camarillo, CA, US - Received
- December 6, 2000
- Decision date
- May 31, 2001
- 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
Other 510(k)s with product code LIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K222613 | ARX Liquid Amies Collection & Transport SystemLIO · Traditional | Arx Sciences, Inc. | 03/27/2024SE |
| K131630 | Puritan Amies Medium Collection and Transport SystemLIO · Traditional | Puritan Medical Products, LLC | 10/21/2013SE |
| K120846 | Transport Culture Medium DeviceLIO · Traditional | Puritan Medical Products, LLC | 06/08/2012SE |
| K103805 | Medical Wire & Equipment S-Transwab (or Sigma-Transwab) Liquid Amies Collection and…LIO · Special | Medical Wire & Equipment Company (Bath), Ltd. | 01/25/2011SE |
| K082472 | Virocult, Model MW950LIO · Abbreviated | Medical Wire & Equipment Company (Bath), Ltd. | 12/30/2008SE |
| K070062 | Coproset Salmonella and Shigella, Uriset Preservative Tubes and Swab Set General UseLIO · Traditional | Diesse Diagnostica Senese S.P.A. | 07/30/2007SE |
| K013711 | Bacti-Swab DryLIO · Traditional | Remel Co. | 11/26/2001SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | Hdc Corp. | 03/15/1999SE |
| K981391 | Par-OneLIO · Traditional | Remel, Inc. | 07/14/1998SE |
| K964144 | Paracon Plus Formalin - Pcp-F, Paracon Plus Saf - Pcp-Saf and Paracon Plus MF - Pcp-MfLIO · Traditional | Para Scientific Co. | 11/27/1996SE |
More from Para Scientific Co.
| 510(k) | Device | Decision |
|---|---|---|
| K972726 | Snap Swab Culture Collection and Transport SystemJSM · Traditional | 10/08/1997SE |
| K970597 | Culture-Pak Collection and Transport System with Clinical Transport Media (Cary-Blair…JSM · Traditional | 03/24/1997SE |
| K964637 | Culture Collection and Transport System, Modified Amies MediaJSM · Traditional | 12/24/1996SE |
| K936078 | Culture-Pak Collection/Transport System, ModifiedJSM · Traditional | 08/16/1994SE |
| K932337 | Culture-Pak Collection and Transport SystemJSM · Traditional | 08/16/1994SE |
| K915454 | Chlamydia Trachomatis Specimen Collection KitLIO · Traditional | 04/08/1992SE |
| K881105 | Culture Collection DeviceJSM · Traditional | 04/25/1988SE |
| K870398 | Pap-Pak Cytobrush KitHHT · Traditional | 02/25/1987SE |
| K864323 | Cytology BrushesHHT · Traditional | 01/09/1987SE |
Questions and answers
When was Nat - Nucleic Acid Transport cleared by the FDA?
Nat - Nucleic Acid Transport (K003761) received a 510(k) decision of Substantially Equivalent on May 31, 2001, 176 days after the submission was received.
What is the product code of K003761?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.