The following data is part of a premarket notification filed by U. S. Diagnostics, Inc. with the FDA for Coagulation Control, Level I.
Device ID | K870685 |
510k Number | K870685 |
Device Name: | COAGULATION CONTROL, LEVEL I |
Classification | System, Multipurpose For In Vitro Coagulation Studies |
Applicant | U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
Contact | Roy E Speck |
Correspondent | Roy E Speck U. S. DIAGNOSTICS, INC. P.O. BOX 4522 3443 MIGUELITO COURT San Luis Obispo, CA 93401 |
Product Code | JPA |
CFR Regulation Number | 864.5425 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-02-19 |
Decision Date | 1987-04-20 |