The following data is part of a premarket notification filed by E K Ind., Inc. with the FDA for Picric Acid Saturated Solution.
Device ID | K842922 |
510k Number | K842922 |
Device Name: | PICRIC ACID SATURATED SOLUTION |
Classification | Fixative, Acid Containing |
Applicant | E K IND., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | LDW |
CFR Regulation Number | 864.4010 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1984-07-25 |
Decision Date | 1984-09-07 |