The following data is part of a premarket notification filed by Chrono-log Corp. with the FDA for Ristocetin Cofactor Assay Kit.
| Device ID | K945414 |
| 510k Number | K945414 |
| Device Name: | RISTOCETIN COFACTOR ASSAY KIT |
| Classification | Test, Qualitative And Quantitative Factor Deficiency |
| 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 | GGP |
| CFR Regulation Number | 864.7290 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-07 |
| Decision Date | 1995-01-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00811476010291 | K945414 | 000 |
| 00811476010161 | K945414 | 000 |
| 00811476010130 | K945414 | 000 |
| 00811476010123 | K945414 | 000 |
| 00811476010017 | K945414 | 000 |
| 00811476010000 | K945414 | 000 |