SLT Microplate Washer
FDA 510(k) K910740 · Tecan U.S., Ltd.
510(k) numberK910740
Submission
- Device name
- SLT Microplate Washer
- Applicant
- Tecan U.S., Ltd.
Hillsborough, NC, US - Received
- February 21, 1991
- Decision date
- March 27, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2300
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJQ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K013371 | UBIT-IR300 Infrared Spectrometry SystemJJQ · Traditional | Otsuka Pharmaceutical Co., Ltd. | 12/21/2001SE |
| K980120 | Digene DML 2000 Microplate LuminometerJJQ · Traditional | Digene Corp. | 02/06/1998SE |
| K973938 | Alpha 4 LS Automated Microtiterplate Processor and ReaderJJQ · Traditional | Sfri, Inc. | 02/04/1998SE |
| K974762 | Stat TracksJJQ · Traditional | Awareness Technology, Inc. | 01/28/1998SE |
| K962113 | Anthos Phacts Version Microplate ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 11/05/1996SE |
| K961183 | Cbi 7520 ReaderJJQ · Traditional | Columbia Bioscience, Inc. | 08/02/1996SE |
| K962166 | Origen AnalyzerJJQ · Traditional | Igen, Inc. | 07/31/1996SE |
| K955077 | Anthos 2010 ReaderJJQ · Traditional | Anthos Labtec, Inc. | 12/04/1995SE |
| K953710 | ELX808 Automated Microplate ReadersJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/25/1995SE |
| K953572 | ELX800UVJJQ · Traditional | Bio-Tek Instruments, Inc. | 10/19/1995SE |
More from Bio-Tek Instruments, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K963268 | Genesis RMPJRA · Traditional | 03/18/1997SE |
| K953345 | GenesisJQW · Traditional | 11/21/1995SE |
| K944556 | 4 Channel DispenserJQW · Traditional | 10/25/1994SE |
| K942655 | 4 Channel DispenserJQW · Traditional | 09/02/1994SE |
| K933996 | ProfiblotKPA · Traditional | 01/28/1994SE |
| K915492 | RSP Mega Sample ProcessorJQW · Traditional | 02/21/1992SE |
| K912036 | Robotic Sample ProcessorJQW · Traditional | 07/26/1991SE |
| K894126 | Robotic Sample ProcessorJQW · Traditional | 08/15/1989SE |
| K854406 | Tecan Robotic Sample Processor(Rsp) #500JQW · Traditional | 02/10/1986SE |
Questions and answers
When was SLT Microplate Washer cleared by the FDA?
SLT Microplate Washer (K910740) received a 510(k) decision of Substantially Equivalent on March 27, 1991, 34 days after the submission was received.
What is the product code of K910740?
The FDA product code is JJQ – Colorimeter, Photometer, Spectrophotometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2300.