The following data is part of a premarket notification filed by Olympus Life & Material Science Europa Gmbh (irish with the FDA for Olympus D-dimer Reagent, Model Osr6x135, Olympus D-dimer Calibrator, Model Odr3033, Olympus D-dimer Control.
Device ID | K070453 |
510k Number | K070453 |
Device Name: | OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL |
Classification | Fibrin Split Products |
Applicant | OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH 3131 WEST ROYAL LANE Irving, TX 75063 -3104 |
Contact | Stephanie G Schwartz |
Correspondent | Stephanie G Schwartz OLYMPUS LIFE & MATERIAL SCIENCE EUROPA GMBH (IRISH 3131 WEST ROYAL LANE Irving, TX 75063 -3104 |
Product Code | GHH |
CFR Regulation Number | 864.7320 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-02-16 |
Decision Date | 2007-06-11 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
15099590080884 | K070453 | 000 |
15099590070588 | K070453 | 000 |
15099590000332 | K070453 | 000 |