K850333 is an FDA 510(k) clearance for the PUMP TUBE SETS FOR HEMA-TEK I & II SLIDE STAINERS. This device is classified as a Slide Stainer, Automated (Class I - General Controls, product code KPA).
Submitted by Shaban Mfg. Co. (Fort Myers, US). The FDA issued a Cleared decision on February 27, 1985, 30 days after receiving the submission on January 28, 1985.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.3800.
| 510(k) Number | K850333 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 28, 1985 |
| Decision Date | February 27, 1985 |
| Days to Decision | 30 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KPA — Slide Stainer, Automated |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3800 |