The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Lumi-aggregometer.
| Device ID | K771198 |
| 510k Number | K771198 |
| Device Name: | LUMI-AGGREGOMETER |
| Classification | Aggregometer, Platelet, Photo-optical Scanning |
| Applicant | CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Contact | Arthur Freilich |
| Correspondent | Arthur Freilich CHRONO-LOG CORP. 2 WEST PARK RD. Havertown, PA 19083 |
| Product Code | JBY |
| CFR Regulation Number | 864.6675 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-07-01 |
| Decision Date | 1977-08-02 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811476010956 | K771198 | 000 |
| 00811476010253 | K771198 | 000 |
| 00811476010246 | K771198 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() LUMI-AGGREGOMETER 73138730 1114418 Dead/Cancelled |
Chrono-Log Corporation 1977-08-24 |