K881187 is an FDA 510(k) clearance for the NATELSON TUBES, HEPARIN AND PLAIN. This device is classified as a Tube, Collection, Capillary Blood (Class I - General Controls, product code GIO).
Submitted by Helps Products, Inc. (Orlando, US). The FDA issued a Cleared decision on May 6, 1988, 46 days after receiving the submission on March 21, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6150.
| 510(k) Number | K881187 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 21, 1988 |
| Decision Date | May 06, 1988 |
| Days to Decision | 46 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GIO — Tube, Collection, Capillary Blood |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6150 |