The following data is part of a premarket notification filed by Trace Analytical with the FDA for Trace Analytical Reduction Gas Analyz.
| Device ID | K820025 |
| 510k Number | K820025 |
| Device Name: | TRACE ANALYTICAL REDUCTION GAS ANALYZ |
| Classification | Chromatography(gas), Clinical Use |
| Applicant | TRACE ANALYTICAL 803 N. Front St. Suite 3 McHenry, IL 60050 |
| Product Code | KZQ |
| CFR Regulation Number | 862.2250 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1982-01-05 |
| Decision Date | 1982-02-15 |