The following data is part of a premarket notification filed by Sebia with the FDA for Capillarys Neonat Hb (pn 2006).
Device ID | K091283 |
510k Number | K091283 |
Device Name: | CAPILLARYS NEONAT HB (PN 2006) |
Classification | Abnormal Hemoglobin Quantitation |
Applicant | SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
Contact | Karen Anderson |
Correspondent | Karen Anderson SEBIA 1705 CORPORATE DRIVE SUITE 400 Norcross, GA 30093 |
Product Code | GKA |
CFR Regulation Number | 864.7415 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2009-05-01 |
Decision Date | 2010-02-22 |