The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Response.
Device ID | K983475 |
510k Number | K983475 |
Device Name: | HEMOCHRON RESPONSE |
Classification | Instrument, Coagulation |
Applicant | INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
Contact | John M Clay |
Correspondent | John M Clay INTERNATIONAL TECHNIDYNE CORP. 8 OLSEN AVE. Edison, NJ 08820 |
Product Code | KQG |
CFR Regulation Number | 864.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1998-10-02 |
Decision Date | 1999-05-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10711234520062 | K983475 | 000 |
10711234520055 | K983475 | 000 |
10711234520017 | K983475 | 000 |