K840500 is an FDA 510(k) clearance for the SEDIPLAST. This device is classified as a Test, Erythrocyte Sedimentation Rate (Class I - General Controls, product code JPH).
Submitted by Precision Technology, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 21, 1984, 15 days after receiving the submission on February 6, 1984.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.6700.
| 510(k) Number | K840500 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 06, 1984 |
| Decision Date | February 21, 1984 |
| Days to Decision | 15 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JPH — Test, Erythrocyte Sedimentation Rate |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.6700 |