Guamstainer
FDA 510(k) K811697 · Tomtec
510(k) numberK811697
Submission
- Device name
- Guamstainer
- Applicant
- Tomtec
Mchenry, IL, US - Received
- June 16, 1981
- Decision date
- July 2, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code KPA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K933996 | ProfiblotKPA · Traditional | Tecan U.S., Ltd. | 01/28/1994SE |
| 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 |
More from Shaban Mfg. Co.
| 510(k) | Device | Decision |
|---|---|---|
| K771569 | Autostreaker · Traditional | 10/25/1977SE |
Questions and answers
When was Guamstainer cleared by the FDA?
Guamstainer (K811697) received a 510(k) decision of Substantially Equivalent on July 2, 1981, 16 days after the submission was received.
What is the product code of K811697?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.