Atlas FDA

BSM 2000 DIALYSIS MACHINE - MODIFIED

FDA 510(k) clearance K850569 · decided 1985-03-12

Clearance details

K-number
K850569
Device name
BSM 2000 DIALYSIS MACHINE - MODIFIED
Applicant
Organon Teknika Corp.
Decision
Substantially Equivalent
Date received
1985-02-12
Decision date
1985-03-12
Days to decision
28 days
Clearance type
Traditional
Product code
FKP
Device class
2
Regulation number
876.5820
Medical specialty
Gastroenterology, Urology
Advisory committee
Gastroenterology, Urology
Location
Oklahoma City, OK, 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
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018/S001)Organon Teknika Corp.1990-03-21
HEPANOSTIKA(TM) HBEAG/ANTI HBE MICROELISA(TM) SYST (P840070/S001)Organon Teknika Corp.1990-03-21
9EPANOSTIKA(TM) ANTI-HAV IGM (P830017/S001)Organon Teknika Corp.1990-03-21
AUTOBAC MIC TEST SYSTEM (N50524/S033)Organon Teknika Corp.1990-01-22
AUTOBAC MIC TEST SYSTEM (N50524/S035)Organon Teknika Corp.1989-12-07
AUTOBAC MIC TEST SYSTEM (N50524/S032)Organon Teknika Corp.1989-06-13
HEPANOSTIKA(TM) ANTI-HAV MIDROELISA SYSTEM (P830018)Organon Teknika Corp.1989-02-06
AUTOBAC MIC TEST SYSTEM (N50524/S031)Organon Teknika Corp.1988-12-28