The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Itc Whole Blood Control Normal/abnormal Level I Or Ii.
| Device ID | K944691 |
| 510k Number | K944691 |
| Device Name: | ITC WHOLE BLOOD CONTROL NORMAL/ABNORMAL LEVEL I OR II |
| Classification | Plasma, Coagulation Control |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Robert N Borghese |
| Correspondent | Robert N Borghese INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Product Code | GGN |
| CFR Regulation Number | 864.5425 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-23 |
| Decision Date | 1995-03-15 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08426950452737 | K944691 | 000 |
| 10711234107034 | K944691 | 000 |
| 10711234107041 | K944691 | 000 |
| 10711234107065 | K944691 | 000 |
| 10711234107072 | K944691 | 000 |
| 10711234107096 | K944691 | 000 |
| 10711234107102 | K944691 | 000 |
| 10711234170175 | K944691 | 000 |
| 10711234170236 | K944691 | 000 |
| 08426950452683 | K944691 | 000 |
| 08426950452713 | K944691 | 000 |
| 08426950088639 | K944691 | 000 |
| 08426950452690 | K944691 | 000 |
| 08426950452706 | K944691 | 000 |
| 10711234107027 | K944691 | 000 |