Atlas FDA

INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5

FDA 510(k) clearance K081769 · decided 2009-05-28

Clearance details

K-number
K081769
Device name
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2008-06-23
Decision date
2009-05-28
Days to decision
339 days
Clearance type
Traditional
Product code
JBQ
Device class
2
Regulation number
864.7060
Medical specialty
Hematology
Advisory committee
Hematology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550)Instrumentation Laboratory CO2002-08-27
COAMATIC AT-400 (K022195)Instrumentation Laboratory CO2002-08-07
IL TEST LIQUID ANTITHROMBIN (K994238)Instrumentation Laboratory CO2000-06-23
K-ASSAY AT-III (K000361)Kamiya Biomedical Co.2000-04-26
IL TEST ANTITHROMBIN (K980499)Instrumentation Laboratory CO1998-04-02
IMMAGE IMMUNOCHEMISTRY SYSTEM ANTITHROMBIN III (AT3) REAGENT (K974110)Beckman Instruments, Inc.1997-12-24

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

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ADVIA Centaur® Complexed PSA (cPSA) Immunoassay; Atellica IM Complexed Prostate-Specific Antigen (cPSA) (P990055/S029)Siemens Healthcare Diagnostics2025-07-16
Dimension TPSA Flex reagent cartridge (P000021/S047)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S042)Siemens Healthcare Diagnostics2025-05-22
Dimension FPSA Flex reagent cartridge (P020027/S041)Siemens Healthcare Diagnostics2025-02-24
Dimension TPSA Flex reagent cartridge (P000021/S046)Siemens Healthcare Diagnostics2025-02-24