Entero-Test HP, Model #102-01
FDA 510(k) K983119 · Hdc Corp.
510(k) numberK983119
Submission
- Device name
- Entero-Test HP, Model #102-01
- Applicant
- Hdc Corp.
San Jose, CA, US - Received
- September 8, 1998
- Decision date
- March 15, 1999
- 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 |
| K003761 | Nat - Nucleic Acid TransportLIO · Traditional | Medical Packaging Corp. | 05/31/2001SE |
| 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 |
|---|---|---|
| K071875 | V-Cath Poly PiccLJS · Traditional | 11/05/2007SE |
| K023342 | Neuro-Trace III Kit, Neuro-Trace III Regional Block Cable, Neuro-Trace III Nerve Mapping…KOI · Traditional | 03/02/2004SE |
| K033853 | Modification to V-Cath Poly PiccFOZ · Special | 01/14/2004SE |
| K032404 | Seldinger Safety Needle IntroducerDYB · Special | 09/10/2003SE |
| K022752 | Pandin Continuous Nerve Stimulating Catheter, Models 561-18-05, 561-18-09, 561-18-15…CAZ · Traditional | 09/09/2003SE |
| K022099 | Safe-T-Peel Safety Needle/Introducer, Models 350-300 S, 360-300'S,380-300'S,390-300'SFOZ · Traditional | 09/20/2002SE |
| K010425 | Epidural Catheter with Connector (and Accessory)KNF · Special | 03/15/2001SE |
| K994059 | Cla Kit (Continuous Local Anesthesia), Model 551-17, 551-10, 551-07CAZ · Traditional | 10/13/2000SE |
| K002770 | Ibis Chemo-Port Implantable Vascular Access System, Model…LJT · Special | 09/26/2000SE |
| K983916 | V-Cath Picc (Peripherally Inserted Central Catheter)FOZ · Special | 11/23/1998SE |
Questions and answers
When was Entero-Test HP, Model #102-01 cleared by the FDA?
Entero-Test HP, Model #102-01 (K983119) received a 510(k) decision of Substantially Equivalent on March 15, 1999, 188 days after the submission was received.
What is the product code of K983119?
The FDA product code is LIO – Device, Specimen Collection, a Class I (low risk) device regulated under 21 CFR 866.2900.