Starswab Culture Collection and Transport System
FDA 510(k) K960997 · Starplex Scientific, Inc.
510(k) numberK960997
Submission
- Device name
- Starswab Culture Collection and Transport System
- Applicant
- Starplex Scientific, Inc.
Etobicoke, Ontario, CA - Received
- March 12, 1996
- Decision date
- April 3, 1996
- 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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| 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 |
|---|---|---|
| K032246 | Modification to Multitrans Culture Collection and Transport SystemJSM · Special | 08/13/2003SE |
| K022388 | Startox Drug of Abuse Screening Test (4)DJC · Traditional | 02/27/2003SE |
| K021006 | Startox Drug of Abuse Screening TestDKZ · Traditional | 06/10/2002SE |
| K962843 | Multitrans Culture Collection and Transport SystemJSM · Traditional | 09/18/1996SE |
| K944847 | Kultsure/Starswab Anaerobic Transport SystemJSL · Traditional | 02/16/1995SE |
| K924364 | Vacuplus Tubes with Grey StoppersJKA · Traditional | 03/01/1993SE |
| K924362 | Vacuplus Tubes with Lavander StoppersJKA · Traditional | 03/01/1993SE |
| K924361 | Vacuplus Tubes with Green StoppersJKA · Traditional | 03/01/1993SE |
| K924363 | Vacuplus(R) Star-Sep(Tm)JKA · Traditional | 02/08/1993SE |
| K924365 | Vacuplus Tubes with Brick Red StoppersJKA · Traditional | 12/28/1992SE |
Questions and answers
When was Starswab Culture Collection and Transport System cleared by the FDA?
Starswab Culture Collection and Transport System (K960997) received a 510(k) decision of Substantially Equivalent on April 3, 1996, 22 days after the submission was received.
What is the product code of K960997?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.