Specimen Container
FDA 510(k) K896794 · Westmark, Sterile Packing Systems, Inc. (Sps)
510(k) numberK896794
Submission
- Device name
- Specimen Container
- Applicant
- Westmark, Sterile Packing Systems, Inc. (Sps)
Grand Rapids, MI, US - Received
- December 1, 1989
- Decision date
- March 1, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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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|---|---|---|---|
| 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 |
| K003761 | Nat - Nucleic Acid TransportLIO · Traditional | Medical Packaging Corp. | 05/31/2001SE |
| K983119 | Entero-Test HP, Model #102-01LIO · Traditional | Hdc Corp. | 03/15/1999SE |
| K981391 | Par-OneLIO · Traditional | Remel, Inc. | 07/14/1998SE |
More from Remel, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K896800 | Irrigation TrayKYZ · Traditional | 05/24/1990SESK |
| K896799 | Paracervical/Pudendal TraysCAZ · Traditional | 04/23/1990SE |
| K896559 | Infant Feeding TubeFPD · Traditional | 03/13/1990SE |
| K896806 | Catheter Plug/ProtectorKNY · Traditional | 02/26/1990SE |
| K896798 | Tracheostomy TrayBTO · Traditional | 02/22/1990SE |
| K896797 | Suction Catheter KitBSY · Traditional | 02/16/1990SE |
| K896215 | Mercy Hip/Knee PackKKX · Traditional | 02/13/1990SE |
| K896804 | ManifoldGCX · Traditional | 02/08/1990SE |
| K896563 | Tubing ConnectorsGCX · Traditional | 02/06/1990SE |
| K896562 | StopcockGCX · Traditional | 02/06/1990SE |
Questions and answers
When was Specimen Container cleared by the FDA?
Specimen Container (K896794) received a 510(k) decision of Substantially Equivalent on March 1, 1990, 90 days after the submission was received.
What is the product code of K896794?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.