Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K981084
Device Classification Name
Kit, Screening, Urine
More FDA Info for this Device
510(K) Number
K981084
Device Name
Kit, Screening, Urine
Applicant
DIATECH DIAGNOSTICS,INC.
15 OAK ST.
BEVERLY FARMS, MA 01915 US
Other 510(k) Applications for this Company
Contact
FRAN WHITE
Other 510(k) Applications for this Contact
Regulation Number
866.2660
More FDA Info for this Regulation Number
Classification Product Code
JXA
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/25/1998
Decision Date
10/07/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
MI - Microbiology
Review Advisory Committee
MI - Microbiology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact