K941291 is an FDA 510(k) clearance for the MONOJECT SAMPLETTE SEPARATOR TUBE. This device is classified as a Tube, Collection, Capillary Blood (Class I - General Controls, product code GIO).
Submitted by Sherwood Medical Co. (St.Louis, US). The FDA issued a Cleared decision on October 27, 1994, 224 days after receiving the submission on March 17, 1994.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 864.6150.
| 510(k) Number | K941291 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 17, 1994 |
| Decision Date | October 27, 1994 |
| Days to Decision | 224 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | Summary PDF |
| Product Code | GIO — Tube, Collection, Capillary Blood |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6150 |