The following data is part of a premarket notification filed by Technalysis, Inc. with the FDA for Hemaview Darkfield Microscope System.
| Device ID | K885091 |
| 510k Number | K885091 |
| Device Name: | HEMAVIEW DARKFIELD MICROSCOPE SYSTEM |
| Classification | Microscope, Phase Contrast |
| Applicant | TECHNALYSIS, INC. 23180 DEL LAGO Laguna Hills, CA 92653 |
| Contact | Jeffrey J Katke |
| Correspondent | Jeffrey J Katke TECHNALYSIS, INC. 23180 DEL LAGO Laguna Hills, CA 92653 |
| Product Code | IBM |
| CFR Regulation Number | 864.3600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-12 |
| Decision Date | 1989-06-13 |