Centrifichem Pipettor Accuracy Calib.
FDA 510(k) K802520 · Union Carbide Corp.
510(k) numberK802520
Submission
- Device name
- Centrifichem Pipettor Accuracy Calib.
- Applicant
- Union Carbide Corp.
Mchenry, IL, US - Received
- October 15, 1980
- Decision date
- November 12, 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 |
|---|---|---|
| K830337 | Mark III Oxygen Walker Sys-Low PressBYJ · Traditional | 03/17/1983SE |
| K820836 | Mark III Oxygen Walker SystemBYJ · Traditional | 04/15/1982SE |
| K820535 | Laser Gas MixturesEWG · Traditional | 03/31/1982SE |
| K812536 | Linde Mark IIBYJ · Traditional | 09/23/1981SE |
| K810732 | Linde Mark II Oxygen Reserv. Type OR-4BYJ · Traditional | 03/27/1981SE |
| K810596 | Centrifi Chem System 400 AnalyzerJJE · Traditional | 03/17/1981SE |
| K810129 | Centrifichem System 500JJE · Traditional | 02/02/1981SE |
| K803216 | Centrifichem Ast/Sgot Optimized ReagentCIT · Traditional | 01/09/1981SE |
| K802741 | Centrifichem Comb. Serum-Based Calib.JIX · Traditional | 12/10/1980SE |
| K802436 | Centrifichem AlbuminCIX · Traditional | 10/31/1980SE |
Questions and answers
When was Centrifichem Pipettor Accuracy Calib. cleared by the FDA?
Centrifichem Pipettor Accuracy Calib. (K802520) received a 510(k) decision of Substantially Equivalent on November 12, 1980, 28 days after the submission was received.
What is the product code of K802520?
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.