The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Control Act Test Tube Normal/abnor. I/ii.
| Device ID | K882481 |
| 510k Number | K882481 |
| Device Name: | HEMOCHRON CONTROL ACT TEST TUBE NORMAL/ABNOR. I/II |
| Classification | Plasma, Coagulation Control |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Les Heimann |
| Correspondent | Les Heimann 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 | 1988-06-16 |
| Decision Date | 1988-08-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234102206 | K882481 | 000 |