Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K973345
Device Classification Name
Calibrator, Multi-Analyte Mixture
More FDA Info for this Device
510(K) Number
K973345
Device Name
Calibrator, Multi-Analyte Mixture
Applicant
VERICHEM LABORATORIES, INC.
90 NARRAGANSETT AVE.
PROVIDENCE, RI 02907 US
Other 510(k) Applications for this Company
Contact
ANTHONY J DIMONTE
Other 510(k) Applications for this Contact
Regulation Number
862.1150
More FDA Info for this Regulation Number
Classification Product Code
JIX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/05/1997
Decision Date
10/29/1997
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CH - Clinical Chemistry
Review Advisory Committee
CH - Clinical Chemistry
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact