The following data is part of a premarket notification filed by Texas Intl. Laboratories, Inc. with the FDA for Clot 2 Semiautomatic Coagulation Analyzer.
Device ID | K900685 |
510k Number | K900685 |
Device Name: | CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZER |
Classification | Instrument, Coagulation |
Applicant | TEXAS INTL. LABORATORIES, INC. 50 SARGENT ST. Needham, MA 02192 |
Contact | Robert P Cogan |
Correspondent | Robert P Cogan TEXAS INTL. LABORATORIES, INC. 50 SARGENT ST. Needham, MA 02192 |
Product Code | KQG |
CFR Regulation Number | 864.5400 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-02-12 |
Decision Date | 1990-04-16 |