K761304 is an FDA 510(k) clearance for the JTB 700 HEMATOLOGY ANALYZER. This device is classified as a Red-cell Indices, Calculated (Class II - Special Controls, product code JPJ).
Submitted by J.T. Baker Chemical Co. (Mchenry, US). The FDA issued a Cleared decision on February 1, 1977, 41 days after receiving the submission on December 22, 1976.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5300.
| 510(k) Number | K761304 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 22, 1976 |
| Decision Date | February 01, 1977 |
| Days to Decision | 41 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JPJ — Red-cell Indices, Calculated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5300 |