CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
FDA 510(k) clearance K850157 · decided 1985-02-27
Clearance details
- K-number
- K850157
- Device name
- CANNULAS FOR HEMA-TEK I & KK SLIDE STAINERS
- Applicant
- Shaban Mfg. Co.
- Decision
- Substantially Equivalent
- Date received
- 1985-01-15
- Decision date
- 1985-02-27
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- KPA
- Device class
- 1
- Regulation number
- 864.3800
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- Location
- Fort Myers, FL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| PROFIBLOT (K933996) | Tecan U.S., Ltd. | 1994-01-28 |
| VERSABLOT (K884258) | American Bionetics, Inc. | 1988-12-14 |
| WESCOR MODEL 7300 AEROSPRAY GRAM STAINER (K881592) | Wescor, Inc. | 1988-05-13 |
| LX-100 SLIDE STAINER (K880745) | Innovative Medical Systems, Inc. | 1988-04-27 |
| WESBLOT PROCESSOR (K874887) | American Bionetics, Inc. | 1988-03-24 |
| SAKURA DRS-60 AUTOMATIC SLIDE STAINER (K874897) | Sakura Finetek U.S.A., Inc. | 1988-01-05 |
| HISTOMATIC SLIDE STAINER, CODE-ON VERSION (K872916) | Fisher Scientific Co., LLC | 1987-09-14 |
| MST-1050-II X-RAY UNIT (K853210) | Radiological Engineering, Inc. | 1985-10-10 |
| PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS (K850333) | Shaban Mfg. Co. | 1985-02-27 |
| MIDAS II AUTOMATIC STAINER (K842077) | Innovative Medical Systems, Inc. | 1984-07-27 |
| WESCOR 7100 AEROSPRAY SLIDE STAINER (K833295) | Wescor, Inc. | 1983-10-31 |
| MIDAS 6000 AUTOMATIC STAINER (K832994) | Innovative Medical Systems, Inc. | 1983-09-29 |
Recalls involving this device
No recalls on record reference this clearance.