The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Kaolin-activated Heparin And Protamine Dosing Assays.
| Device ID | K010193 |
| 510k Number | K010193 |
| Device Name: | HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS |
| Classification | Assay, Heparin |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | John Clay |
| Correspondent | John Clay INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | KFF |
| CFR Regulation Number | 864.7525 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-01-22 |
| Decision Date | 2001-06-06 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234202111 | K010193 | 000 |
| 10711234202104 | K010193 | 000 |
| 10711234202098 | K010193 | 000 |
| 10711234202081 | K010193 | 000 |