The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for Flame Photometer T281-t282-t283.
Device ID | K832886 |
510k Number | K832886 |
Device Name: | FLAME PHOTOMETER T281-T282-T283 |
Classification | Flame Emission Photometer For Clinical Use |
Applicant | TEXAS INTL. LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JJO |
CFR Regulation Number | 862.2540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-08-26 |
Decision Date | 1983-12-08 |