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 |