The following data is part of a premarket notification filed by International Technidyne Corp. with the FDA for Protamine Response Test Catalogue Number Prt 200.
Device ID | K910105 |
510k Number | K910105 |
Device Name: | PROTAMINE RESPONSE TEST CATALOGUE NUMBER PRT 200 |
Classification | Protamine Sulphate |
Applicant | INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
Contact | Les Heimann |
Correspondent | Les Heimann INTERNATIONAL TECHNIDYNE CORP. 23 NEVSKY ST. Edison, NJ 08820 |
Product Code | GFT |
CFR Regulation Number | 864.7525 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-01-03 |
Decision Date | 1991-02-26 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
10711234202067 | K910105 | 000 |
10711234202050 | K910105 | 000 |
10711234102183 | K910105 | 000 |