Mic-Bioplate Inoculator
FDA 510(k) K803092 · Pasco Laboratories, Inc.
510(k) numberK803092
Submission
- Device name
- Mic-Bioplate Inoculator
- Applicant
- Pasco Laboratories, Inc.
Mchenry, IL, US - Received
- December 8, 1980
- Decision date
- December 22, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|---|
| K023955 | BD Viper InstrumentJQW · Traditional | Becton, Dickinson & CO | 06/24/2003SE |
| 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 |
More from Tecan U.S., Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K042331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 10/07/2004SE |
| K041776 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 08/03/2004SE |
| K041214 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/07/2004SE |
| K033119 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 11/18/2003SE |
| K031727 | Pasco Mic and Mic/Id Panels, GemifloxacinJWY · Traditional | 07/30/2003SE |
| K031205 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 06/13/2003SE |
| K031103 | Pasco Mic and Mic/Id Panels (Ertapenem)JWY · Traditional | 06/12/2003SE |
| K030933 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 05/01/2003SE |
| K030620 | Pasco Mic and Mic/Id PanelsLTT · Traditional | 04/14/2003SE |
| K020331 | Pasco Mic and Mic/Id PanelsJWY · Traditional | 03/20/2002SE |
Questions and answers
When was Mic-Bioplate Inoculator cleared by the FDA?
Mic-Bioplate Inoculator (K803092) received a 510(k) decision of Substantially Equivalent on December 22, 1980, 14 days after the submission was received.
What is the product code of K803092?
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.