The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Itc Hgb Pro Professional Hemoglobin Testing System.
| Device ID | K023561 |
| 510k Number | K023561 |
| Device Name: | ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM |
| Classification | System, Hemoglobin, Automated |
| Applicant | INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison, NJ 08820 |
| Contact | John Clay |
| Correspondent | John Clay INTERNATIONAL TECHNIDYNE CORP. 6 OLSEN AVE. Edison, NJ 08820 |
| Product Code | GKR |
| CFR Regulation Number | 864.5620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-10-23 |
| Decision Date | 2003-01-31 |
| Summary: | summary |