The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Hemochron Electronic System Verification Tube.
Device ID | K990449 |
510k Number | K990449 |
Device Name: | HEMOCHRON ELECTRONIC SYSTEM VERIFICATION TUBE |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
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 | JPA |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1999-02-12 |
Decision Date | 1999-04-13 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10711234540060 | K990449 | 000 |
10711234540053 | K990449 | 000 |
10711234540114 | K990449 | 000 |