K821318 is an FDA 510(k) clearance for the RETIC SET. This device is classified as a Brilliant Cresyl Blue (Class I - General Controls, product code KJN).
Submitted by R&D Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 2, 1982, 29 days after receiving the submission on May 4, 1982.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.1850.
| 510(k) Number | K821318 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 1982 |
| Decision Date | June 02, 1982 |
| Days to Decision | 29 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | KJN — Brilliant Cresyl Blue |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 864.1850 |