The following data is part of a premarket notification filed by Shaban Mfg. Co. with the FDA for Potassium Sodium Analysis Products.
Device ID | K833535 |
510k Number | K833535 |
Device Name: | POTASSIUM SODIUM ANALYSIS PRODUCTS |
Classification | Flame Emission Photometer For Clinical Use |
Applicant | SHABAN MFG. CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | JJO |
CFR Regulation Number | 862.2540 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-27 |
Decision Date | 1983-12-29 |