The following data is part of a premarket notification filed by Dade Behring, Inc. with the FDA for Fibrinogen Calibrator Kit.
Device ID | K072304 |
510k Number | K072304 |
Device Name: | FIBRINOGEN CALIBRATOR KIT |
Classification | Fibrinogen Standard |
Applicant | DADE BEHRING, INC. P.O. BOX 6101; MS 514 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
Contact | Radames Riesgo |
Correspondent | Radames Riesgo DADE BEHRING, INC. P.O. BOX 6101; MS 514 GLASGOW BLDG. 500 Newark, DE 19714 -6101 |
Product Code | GFX |
CFR Regulation Number | 864.7340 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2007-08-17 |
Decision Date | 2007-09-19 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00842768008276 | K072304 | 000 |
00630414640631 | K072304 | 000 |