The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Reagent, Firefly #395.
| Device ID | K781807 |
| 510k Number | K781807 |
| Device Name: | REAGENT, FIREFLY #395 |
| Classification | System, Automated Platelet Aggregation |
| Applicant | CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Contact | Arthur Frelich |
| Correspondent | Arthur Frelich CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-25 |
| Decision Date | 1978-11-22 |