K891574 is an FDA 510(k) clearance for the LITHIUM CONCENTRATE #SR1031, NA/K STANDARDS SR1030. This device is classified as a Flame Photometry, Sodium (Class II - Special Controls, product code JGT).
Submitted by Em Diagnostic Systems, Inc. (Gibbstown, US). The FDA issued a Cleared decision on June 9, 1989, 81 days after receiving the submission on March 20, 1989.
This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1665.
| 510(k) Number | K891574 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 20, 1989 |
| Decision Date | June 09, 1989 |
| Days to Decision | 81 days |
| Submission Type | Traditional |
| Review Panel | Chemistry (CH) |
| Summary | — |
| Product Code | JGT — Flame Photometry, Sodium |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 862.1665 |