The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Chrono-log Whole Blood Lumi-aggregometer, Model 700.
| Device ID | K050265 |
| 510k Number | K050265 |
| Device Name: | CHRONO-LOG WHOLE BLOOD LUMI-AGGREGOMETER, MODEL 700 |
| Classification | System, Automated Platelet Aggregation |
| Applicant | CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Contact | Nicholas J Veriabo |
| Correspondent | Nicholas J Veriabo 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 | 2005-02-04 |
| Decision Date | 2005-10-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811476010499 | K050265 | 000 |
| 00811476010482 | K050265 | 000 |