Device Classification Name |
bilirubin (total and unbound) in the neonate test system
|
510(k) Number |
K042522 |
Device Name |
JAUNDICE METER, MODEL JM 103 |
Applicant |
DRAEGER MEDICAL INFANT CARE, INC. |
330 JACKSONVILLE RD. |
HATBORO,
PA
19040
|
|
Applicant Contact |
THOMAS M MCINTOSH |
Correspondent |
DRAEGER MEDICAL INFANT CARE, INC. |
330 JACKSONVILLE RD. |
HATBORO,
PA
19040
|
|
Correspondent Contact |
THOMAS M MCINTOSH |
Regulation Number | 862.1113
|
Classification Product Code |
|
Date Received | 09/16/2004 |
Decision Date | 07/06/2005 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
FDA Review |
Decision Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|