Cara-Stain Model 3000
FDA 510(k) K771699 · American Safety Equipment Corp.
510(k) numberK771699
Submission
- Device name
- Cara-Stain Model 3000
- Applicant
- American Safety Equipment Corp.
Mchenry, IL, US - Received
- September 6, 1977
- Decision date
- September 13, 1977
- 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 |
|---|---|---|
| K801010 | Kirschner WireHSB · Traditional | 05/20/1980SE |
| K760960 | Surgical Wire DriverDZJ · Traditional | 11/19/1976SE |
| K760956 | Surgical Micro DrillDZA · Traditional | 11/19/1976SE |
| K760958 | Surgical Oscillating SawDZH · Traditional | 11/16/1976SE |
| K760959 | Surgical ChiselEMM · Traditional | 11/15/1976SE |
| K760957 | Surgical Reciprocating SawDZH · Traditional | 11/15/1976SE |
Questions and answers
When was Cara-Stain Model 3000 cleared by the FDA?
Cara-Stain Model 3000 (K771699) received a 510(k) decision of Substantially Equivalent on September 13, 1977, 7 days after the submission was received.
What is the product code of K771699?
The FDA product code is KPA – Slide Stainer, Automated, a Class I (low risk) device regulated under 21 CFR 864.3800.