The following data is part of a premarket notification filed by E K Ind., Inc. with the FDA for Schiff Reagent Fuchsin-sulfurous Acid.
| Device ID | K842919 |
| 510k Number | K842919 |
| Device Name: | SCHIFF REAGENT FUCHSIN-SULFUROUS ACID |
| Classification | Reagent, Schiff |
| Applicant | E K IND., INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | HZT |
| CFR Regulation Number | 864.1850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-25 |
| Decision Date | 1984-09-11 |