Mi Das 1000 Automatic Slide Stainer
FDA 510(k) K821830 · Innovative Medical Systems, Inc.
510(k) numberK821830
Submission
- Device name
- Mi Das 1000 Automatic Slide Stainer
- Applicant
- Innovative Medical Systems, Inc.
Mchenry, IL, US - Received
- June 22, 1982
- Decision date
- July 22, 1982
- 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 |
|---|---|---|
| K973035 | Viola II Dental Camera SystemEIA · Traditional | 09/24/1997SE |
| K951469 | Bazooka SystemFNM · Traditional | 06/28/1995SE |
| K933184 | Positive Airway Pressure SystemBZD · Traditional | 11/28/1994SE |
| K924590 | Microwave Automated Tissue ProcessorIEO · Traditional | 12/29/1992SE |
| K922081 | Labotech Automated Microtiter AnalyzerJJQ · Traditional | 09/02/1992SE |
| K921005 | AutoloaderJQW · Traditional | 04/29/1992SE |
| K915457 | Phaco 20/20 System IHQC · Traditional | 02/24/1992SE |
| K915456 | Phaco 3000 LinearHQC · Traditional | 02/12/1992SE |
| K883599 | LX-80 Automated Tissue Processor (Plastic)IEO · Traditional | 09/02/1988SE |
| K880745 | LX-100 Slide StainerKPA · Traditional | 04/27/1988SE |
Questions and answers
When was Mi Das 1000 Automatic Slide Stainer cleared by the FDA?
Mi Das 1000 Automatic Slide Stainer (K821830) received a 510(k) decision of Substantially Equivalent on July 22, 1982, 30 days after the submission was received.
What is the product code of K821830?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.