Device Classification Name |
Calibrator, Multi-Analyte Mixture
|
510(k) Number |
K972333 |
Device Name |
AMMONIA/IRON STANDARD KIT |
Applicant |
VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. |
PROVIDENCE,
RI
02907
|
|
Applicant Contact |
ANTHONY J DIMONTE |
Correspondent |
VERICHEM LABORATORIES, INC. |
90 NARRAGANSETT AVE. |
PROVIDENCE,
RI
02907
|
|
Correspondent Contact |
ANTHONY J DIMONTE |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 06/23/1997 |
Decision Date | 07/23/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|