The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Jr. Microcoagulation Low Range Act.
| Device ID | K960749 |
| 510k Number | K960749 |
| Device Name: | HEMOCHRON JR. MICROCOAGULATION LOW RANGE ACT |
| Classification | Activated Whole Blood Clotting Time |
| 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 | JBP |
| CFR Regulation Number | 864.7140 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-23 |
| Decision Date | 1996-08-12 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234103081 | K960749 | 000 |