The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Chrono-log Platelet Aggregometer, 4 Channel; Chrono-log Platelet Aggregometer, 8 Channel.
| Device ID | K161329 |
| 510k Number | K161329 |
| Device Name: | Chrono-log Platelet Aggregometer, 4 Channel; Chrono-log Platelet Aggregometer, 8 Channel |
| Classification | System, Automated Platelet Aggregation |
| Applicant | Chrono-log Corp. 2 West Park Road Havertown, PA 19083 |
| Contact | Nicholas J Veriabo |
| Correspondent | Nicholas J Veriabo Chrono-log Corp. 2 West Park Road Havertown, PA 19083 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-05-12 |
| Decision Date | 2016-12-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811476010994 | K161329 | 000 |
| 00811476010987 | K161329 | 000 |