Submission Details
| 510(k) Number | K903306 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 1990 |
| Decision Date | August 29, 1990 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
K903306 is an FDA 510(k) clearance for the TECHNICON CHEM I SYSTEM MAGNESIUM METHOD, a Photometric Method, Magnesium (Class I — General Controls, product code JGJ), submitted by Technicon Instruments Corp. (New York, US). The FDA issued a Cleared decision on August 29, 1990, 36 days after receiving the submission on July 24, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1495.
| 510(k) Number | K903306 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 24, 1990 |
| Decision Date | August 29, 1990 |
| Days to Decision | 36 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGJ — Photometric Method, Magnesium |
| Device Class | Class I — General Controls |
| CFR Regulation | 21 CFR 862.1495 |