The following data is part of a premarket notification filed by Surgipath Medical Industries, Inc. with the FDA for Cytology Fixative.
| Device ID | K770592 |
| 510k Number | K770592 |
| Device Name: | CYTOLOGY FIXATIVE |
| Classification | Preservative, Cytological |
| Applicant | SURGIPATH MEDICAL INDUSTRIES, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | LEA |
| CFR Regulation Number | 864.4010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-03-28 |
| Decision Date | 1977-05-20 |