The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Directcheck Control For Hemochron Jr. Microcoagulation Systems Act-lr Cuvette Directcheck Controls For Hemochron Jr. Mic.
| Device ID | K120977 |
| 510k Number | K120977 |
| Device Name: | DIRECTCHECK CONTROL FOR HEMOCHRON JR. MICROCOAGULATION SYSTEMS ACT-LR CUVETTE DIRECTCHECK CONTROLS FOR HEMOCHRON JR. MIC |
| Classification | Plasma, Coagulation Control |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
| Contact | Lawrence Picciano |
| Correspondent | Lawrence Picciano 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 | 2012-04-02 |
| Decision Date | 2013-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234540046 | K120977 | 000 |
| 10711234170243 | K120977 | 000 |
| 10711234170229 | K120977 | 000 |
| 10711234107089 | K120977 | 000 |
| 10711234107058 | K120977 | 000 |