K811793 is an FDA 510(k) clearance for the FIX-RIGHT 90ML & 180 ML PREFILLED CONT. This device is classified as a Container, Specimen Mailer And Storage, Sterile (Class I - General Controls, product code KDT).
Submitted by Richard-Allan Medical Ind., Inc. (Mchenry, US). The FDA issued a Cleared decision on July 31, 1981, 37 days after receiving the submission on June 24, 1981.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.3250.
| 510(k) Number | K811793 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 24, 1981 |
| Decision Date | July 31, 1981 |
| Days to Decision | 37 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KDT — Container, Specimen Mailer And Storage, Sterile |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.3250 |