Submission Details
| 510(k) Number | K801290 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 30, 1980 |
| Decision Date | June 30, 1980 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K801290 is an FDA 510(k) clearance for the ALIZARIN SULFONATE, CALCIUM, a Alizarin Sulfonate, Calcium (Class II — Special Controls, product code CID), submitted by Union Carbide Corp. (Mchenry, US). The FDA issued a Cleared decision on June 30, 1980, 31 days after receiving the submission on May 30, 1980. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1145.
| 510(k) Number | K801290 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | May 30, 1980 |
| Decision Date | June 30, 1980 |
| Days to Decision | 31 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | CID — Alizarin Sulfonate, Calcium |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 862.1145 |