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510(k) K232904

Device
Access Ostase
Applicant
Beckman Coulter
510(k) number
K232904
Product code
CIN
Decision
Substantially Equivalent (SESE)
Decision date
2024-04-15
Date received
2023-09-18
Regulation
862.1050
Classification name
Electrophoretic Separation, Alkaline Phosphatase Isoenzymes
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Kate Oelberg
Address
1000 Lake Hazeltine Dr. Chaska MN US 55318 55318

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code CIN#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K200475IDS-iSYS Ostase BAPImmunodiagnostic Systems , Ltd.2020-09-30
K043125ORION DIAGNOSTICA UNIQ PINP RIAOrion Diagnostica, OY2005-05-04
K020625SPIFE 2000/3000 ALP 40, 20; MODELS 3345 AND 3346Helena Laboratories2002-05-06
K011113HYDRAGEL ISO-PAL K20 (PN 3022); HYDRAGEL 7 ISO-PAL (PN 4112); HYDRAGEL 15 ISO-PAL (PN 4132)Sebia2001-06-13
K994278ACCESS OSTASE IMMUNOENZYMETRIC ASSAYBeckman Coulter, Inc.2000-03-28
K981373ALKPHASE-B ASSAY KITMetra Biosystems, Inc.1998-05-27
K972666TANDEM-MP OSTASE IMMUNOENZYMETRIC ASSAYHybritech, Inc.1997-09-11
K964764OPUS BONE ALPBehring Diagnostics, Inc.1997-01-24
K961573TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYHybritech, Inc.1996-08-19
K952768ALKPHASE-B ASSAY KITMetra Biosystems, Inc.1995-08-24
K934013RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KITIsolab, Inc.1994-04-26
K930810TANDEM-R OSTASE IMMUNORADIOMETRIC ASSAYHybritech, Inc.1994-01-11
K921578TITAN GEL ALKALINE PHOSPHATASE (HR)Helena Laboratories1992-09-23
K912603REP ALP-15, 8, & 4 KITSHelena Laboratories1991-07-30
K890269ALKALINE PHOSPHATASE ISOENZYME REAGENTSBeckman Instruments, Inc.1989-03-08