The following data is part of a premarket notification filed by Pulse Scientific, Inc. with the FDA for Pulse Im Red Cell Test.
| Device ID | K923767 |
| 510k Number | K923767 |
| Device Name: | PULSE IM RED CELL TEST |
| Classification | System, Test, Infectious Mononucleosis |
| Applicant | PULSE SCIENTIFIC, INC. 5125 HARVESTER ROAD UNIT 6 Burlington, Ont., Canada, CA L7l 6a2 |
| Contact | Allen Chan |
| Correspondent | Allen Chan PULSE SCIENTIFIC, INC. 5125 HARVESTER ROAD UNIT 6 Burlington, Ont., Canada, CA L7l 6a2 |
| Product Code | KTN |
| CFR Regulation Number | 866.5640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-28 |
| Decision Date | 1992-10-16 |