Search
Companies
Product Codes
Device Names
Contacts
Applications
Decisions
Contact
FDA 510(k) Application Details - K982786
Device Classification Name
Device, Automated Cell-Locating
More FDA Info for this Device
510(K) Number
K982786
Device Name
Device, Automated Cell-Locating
Applicant
ACCUMED INTL., INC.
900 NO. FRANKLIN
SUITE 401
CHICAGO, IL 60610 US
Other 510(k) Applications for this Company
Contact
NORMAN J PRESSMAN
Other 510(k) Applications for this Contact
Regulation Number
864.5260
More FDA Info for this Regulation Number
Classification Product Code
JOY
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/10/1998
Decision Date
10/16/1998
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
Search
|
Companies
|
Product Codes
|
Device Names
|
Contacts
|
Applications
|
Decisions
|
Contact