K772036 is an FDA 510(k) clearance for the IN-LINE BURETTE SET. This device is classified as a Set, Administration, Intravascular (Class II - Special Controls, product code FPA).
Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on November 16, 1977, 20 days after receiving the submission on October 27, 1977.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 880.5440.
| 510(k) Number | K772036 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | October 27, 1977 |
| Decision Date | November 16, 1977 |
| Days to Decision | 20 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | FPA — Set, Administration, Intravascular |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 880.5440 |