The following data is part of a premarket notification filed by Accra Laboratories, Inc. with the FDA for Copper Sulfate Solution Sp. Gr.1.055.
| Device ID | K803095 |
| 510k Number | K803095 |
| Device Name: | COPPER SULFATE SOLUTION SP. GR.1.055 |
| Classification | Solution, Copper Sulfate For Specific Gravity Determinations |
| Applicant | ACCRA LABORATORIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | KSL |
| CFR Regulation Number | 864.9320 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-12-08 |
| Decision Date | 1981-03-06 |