Profiblot
FDA 510(k) K933996 · Tecan U.S., Ltd.
510(k) numberK933996
Submission
- Device name
- Profiblot
- Applicant
- Tecan U.S., Ltd.
Hillsborough, NC, US - Received
- August 17, 1993
- Decision date
- January 28, 1994
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Other 510(k)s with product code KPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K884258 | VersablotKPA · Traditional | American Bionetics, Inc. | 12/14/1988SE |
| K881592 | Wescor Model 7300 Aerospray Gram StainerKPA · Traditional | Wescor, Inc. | 05/13/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | Innovative Medical Systems, Inc. | 04/27/1988SE |
| K874887 | Wesblot ProcessorKPA · Traditional | American Bionetics, Inc. | 03/24/1988SE |
| K874897 | Sakura DRS-60 Automatic Slide StainerKPA · Traditional | Sakura Finetek U.S.A., Inc. | 01/05/1988SE |
| K872916 | Histomatic Slide Stainer, Code-On VersionKPA · Traditional | Fisher Scientific Co., LLC | 09/14/1987SE |
| K853210 | MST-1050-II X-Ray UnitKPA · Traditional | Radiological Engineering, Inc. | 10/10/1985SE |
| K850333 | Pump Tube Sets for Hema-Tek I & II Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K850157 | Cannulas for Hema-Tek I & KK Slide StainersKPA · Traditional | Shaban Mfg. Co. | 02/27/1985SE |
| K842077 | Midas II Automatic StainerKPA · Traditional | Innovative Medical Systems, Inc. | 07/27/1984SE |
More from Innovative Medical Systems, 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 |
| K915492 | RSP Mega Sample ProcessorJQW · Traditional | 02/21/1992SE |
| K912036 | Robotic Sample ProcessorJQW · Traditional | 07/26/1991SE |
| K910740 | SLT Microplate WasherJJQ · Traditional | 03/27/1991SE |
| K894126 | Robotic Sample ProcessorJQW · Traditional | 08/15/1989SE |
| K854406 | Tecan Robotic Sample Processor(Rsp) #500JQW · Traditional | 02/10/1986SE |
Questions and answers
When was Profiblot cleared by the FDA?
Profiblot (K933996) received a 510(k) decision of Substantially Equivalent on January 28, 1994, 164 days after the submission was received.
What is the product code of K933996?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.