Novapath C. Trachomatis Direct Spec Collection Kit
FDA 510(k) K871860 · Bio-Rad
510(k) numberK871860
Submission
- Device name
- Novapath C. Trachomatis Direct Spec Collection Kit
- Applicant
- Bio-Rad
Hercules, CA, US - Received
- May 13, 1987
- Decision date
- May 29, 1987
- 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
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 |
| 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 |
|---|---|---|
| K171061 | MRSASelect IIJSO · Traditional | 12/28/2017SE |
| K122187 | Vreselect Culture MediumJSO · Traditional | 11/06/2012SE |
| K103684 | Vreselect Culture MediumJSO · Traditional | 10/21/2011SE |
| K093678 | Platelia Aspergillus Eia Model 62793NOM · Traditional | 01/13/2011SE |
| K100589 | Mrsa Select - Skin and Soft Tissue Wound SpecimensJSO · Traditional | 10/29/2010SE |
| K081362 | Platelia Lyme IgmLSR · Traditional | 06/26/2008SE |
| K081212 | Mrsaselect - Extended IncubationJSO · Traditional | 06/13/2008SE |
| K080012 | Platelia Lyme Igg AssayLSR · Traditional | 05/08/2008SE |
| K070361 | MrsaselectJSO · Traditional | 09/13/2007SE |
| K060641 | Platelia Aspergillus Eia, Model 62793NOM · Traditional | 06/02/2006SE |
Questions and answers
When was Novapath C. Trachomatis Direct Spec Collection Kit cleared by the FDA?
Novapath C. Trachomatis Direct Spec Collection Kit (K871860) received a 510(k) decision of Substantially Equivalent on May 29, 1987, 16 days after the submission was received.
What is the product code of K871860?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.