The following data is part of a premarket notification filed by Erie Scientific Co. with the FDA for Histology Paraffin.
| Device ID | K862141 |
| 510k Number | K862141 |
| Device Name: | HISTOLOGY PARAFFIN |
| Classification | Formulations, Paraffin, All |
| Applicant | ERIE SCIENTIFIC CO. PORTSMOUTH INDUSTRIAL PARK Portsmouth, NH 03801 |
| Contact | Henry N Williams |
| Correspondent | Henry N Williams ERIE SCIENTIFIC CO. PORTSMOUTH INDUSTRIAL PARK Portsmouth, NH 03801 |
| Product Code | KEO |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-06-04 |
| Decision Date | 1986-06-13 |