Company ยท US
Tecan U.S., Ltd.
FDA 510(k) clearances and medical device recalls filed under this name, 1986 to 1997. Name variants (Inc, Corp, punctuation) are merged.
10510(k) clearances (0 in 12 months)
3recalls (0 in 12 months)
2recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 18, 1997 | K963268 | GENESIS RMP Tecan U.S., Inc. | JRA |
| Nov 21, 1995 | K953345 | GENESIS Tecan U.S., Inc. | JQW |
| Oct 25, 1994 | K944556 | 4 CHANNEL DISPENSER Tecan U.S., Inc. | JQW |
| Sep 2, 1994 | K942655 | 4 CHANNEL DISPENSER Tecan U.S., Inc. | JQW |
| Jan 28, 1994 | K933996 | PROFIBLOT Tecan U.S., Ltd. | KPA |
| Feb 21, 1992 | K915492 | RSP MEGA SAMPLE PROCESSOR Tecan U.S., Ltd. | JQW |
| Jul 26, 1991 | K912036 | ROBOTIC SAMPLE PROCESSOR Tecan U.S., Ltd. | JQW |
| Mar 27, 1991 | K910740 | SLT MICROPLATE WASHER Tecan U.S., Ltd. | JJQ |
| Aug 15, 1989 | K894126 | ROBOTIC SAMPLE PROCESSOR Tecan U.S., Ltd. | JQW |
| Feb 10, 1986 | K854406 | TECAN ROBOTIC SAMPLE PROCESSOR(RSP) #500 Tecan U.S., Ltd. | JQW |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 23, 2005 | Tecan U S Inc Disposable Tips 1000 l with filter Conductive disposable tips for Tecan Genesis Series * Order Number 612513.1 * Tecan Schweiz AG Seestrae 103, CH-8708 Mannedorf, Switzerland * Made in Germany. Bliste Terminated |
JQW | None listed |
| Jul 20, 2004 | Tecan U S Inc Tecan Clinical Workstations with Robonet software Terminated |
JQW | K953345 |
| May 29, 2003 | Tecan U S Inc Tecan Genesis RSP and NPS Instruments with barcode scanner type PosID2 option with firmware version 2.45 or lower. Terminated |
JQW | K953345 |