The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Aggro/link Control Software.
Device ID | K932566 |
510k Number | K932566 |
Device Name: | AGGRO/LINK CONTROL SOFTWARE |
Classification | Aggregrometer, Platelet |
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 | JBX |
CFR Regulation Number | 864.6675 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1993-05-27 |
Decision Date | 1993-11-02 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00811476011663 | K932566 | 000 |
00811476011021 | K932566 | 000 |
00811476011007 | K932566 | 000 |