Atlas FDA

RECONSTITUTION ACCESSOREIS

FDA 510(k) clearance K950861 · decided 1995-05-26

Clearance details

K-number
K950861
Device name
RECONSTITUTION ACCESSOREIS
Applicant
Organon, Inc.
Decision
Substantially Equivalent
Date received
1995-02-27
Decision date
1995-05-26
Days to decision
88 days
Clearance type
Traditional
Product code
FPK
Device class
2
Regulation number
880.5440
Medical specialty
General Hospital
Advisory committee
General Hospital
Location
West Orange, NJ, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
GONOSTICON DRI-DOT TEST (N17985/S002)Organon, Inc.1983-01-04
GONOSTICON DRI-DOT (N17985/S001)Organon, Inc.1981-04-14