BD Viper Instrument
FDA 510(k) K023955 · Becton, Dickinson & CO
510(k) numberK023955
Submission
- Device name
- BD Viper Instrument
- Applicant
- Becton, Dickinson & CO
Sparks, MD, US - Received
- November 27, 2002
- Decision date
- June 24, 2003
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JQW – Station, Pipetting And Diluting, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2750
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JQW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K973335 | Quatro SP Sample Processing Systems (200-499, Inclusive)JQW · Traditional | Zenyx Scientific , Ltd. | 04/30/1998SE |
| K980180 | 2700 Sample ManagerJQW · Traditional | Waters Corporation | 02/12/1998SE |
| K970420 | Mastercap Am 5.0/MASTERCAP RM 5.0JQW · Traditional | Pharmacia, Inc. | 06/30/1997SE |
| K970616 | Mini Sampler ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 04/21/1997SE |
| K962687 | Gio. de Vita E C. S.R.L.(Gdv) Automatic Washing SystemJQW · Traditional | Nichols Institute Diagnostics | 03/28/1997SE |
| K962859 | Mini Sample ProcessorJQW · Traditional | Cavro Scientific Instruments, Inc. | 10/29/1996SE |
| K961896 | Microlab 4000, Microlab 4200JQW · Traditional | Hamilton Co. | 08/16/1996SE |
| K961694 | ImpactJQW · Traditional | Matrix Technologies Corp. | 06/21/1996SE |
| K953345 | GenesisJQW · Traditional | Tecan U.S., Inc. | 11/21/1995SE |
| K951753 | Medtec Autoblot 2000JQW · Traditional | Medtec, Inc. | 10/17/1995SE |
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| 510(k) | Device | Decision |
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| K170386 | BD Ultra-Fine Insulin Syringe, BD Ultra-Fine II Insulin Syringe, BD Insulin Syringes…FMF · Special | 04/12/2017SE |
| K163637 | BD Phoenix Automated Microbiology System - GN Ceftazidime/avibactam (0.25/4- 32/4ug/mL)LON · Traditional | 03/21/2017SE |
| K161810 | BD BACTEC Standard/10 Aerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic…MDB · Traditional | 02/09/2017SE |
| K161306 | BD BACTEC Standard Anaerobic/F Culture Vials Soybean-Casein Digest Broth in a Plastic VialMDB · Traditional | 08/08/2016SE |
| K160164 | BD Veritor System for Rapid Detection of Flu A + B Labratory KitPSZ · Special | 02/25/2016SE |
| K160161 | BD Veritor System for Rapid Detection of Flu A + B CLIA waived kitPSZ · Special | 02/24/2016SE |
| K150059 | BD FlowSmart SetFPA · Traditional | 04/28/2015SE |
| K141474 | Becton Dickinson Intelliport SystemPHC · Traditional | 12/18/2014SE |
| K140448 | BD Probetec Neisseria Gonorrhoeae (GC) QX Amplified DNA AssayLSL · Traditional | 05/20/2014SE |
Questions and answers
When was BD Viper Instrument cleared by the FDA?
BD Viper Instrument (K023955) received a 510(k) decision of Substantially Equivalent on June 24, 2003, 209 days after the submission was received.
What is the product code of K023955?
The FDA product code is JQW – Station, Pipetting And Diluting, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2750.