The following data is part of a premarket notification filed by Analox Instruments Ltd. with the FDA for Analox Lm3 Micro-stat Analyser.
| Device ID | K843082 |
| 510k Number | K843082 |
| Device Name: | ANALOX LM3 MICRO-STAT ANALYSER |
| Classification | Analyzer, Chemistry (photometric, Discrete), For Clinical Use |
| Applicant | ANALOX INSTRUMENTS LTD. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | JJE |
| CFR Regulation Number | 862.2160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-06 |
| Decision Date | 1984-10-17 |