Atlas FDA

STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH

FDA 510(k) clearance K111822 · decided 2011-10-26

Clearance details

K-number
K111822
Device name
STA(R) - LIQUID ANTI-XA, MULTI HEP CALIBRATOR, QUALITY HNF / UFH, QUALITY HBPM / LMWH
Applicant
Diagnostica Stago, Inc.
Decision
Substantially Equivalent
Date received
2011-06-28
Decision date
2011-10-26
Days to decision
120 days
Clearance type
Traditional
Product code
KFF
Device class
2
Regulation number
864.7525
Medical specialty
Hematology
Advisory committee
Hematology
Location
Rome, IT
Third-party review
No
Expedited review
No

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Similar devices under this product code

Devices cleared under the same product code - the starting set for predicate research.

RecordFirmDate
HemosIL Liquid Anti-Xa (K213464)Instrumentation Laboratory CO2022-10-04
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ENOXAPARIN TEST CARD (K013305)Cardiovascular Diagnostics, Inc.2002-08-23
ACTICHROME HEPARIN (ANTI-FIIA) (K013637)American Diagnostica, Inc.2002-04-16
ACTICHROME HEPARIN (ANTI-FXA), MODEL 832 (K013318)American Diagnostica, Inc.2002-03-08
ROTACHROM HEPARIN AND STA -ROTACHROM HEPARIN (K010455)Diagnostica-Stago2001-06-07
HEMOCHRON KAOLIN-ACTIVATED HEPARIN AND PROTAMINE DOSING ASSAYS (K010193)International Technidyne Corp.2001-06-06
COAMATIC HEPARIN (K983178)Instrumentation Laboratory CO1998-11-03
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Recalls involving this device

RecordFirmDate
STA-Liquid Anti-Xa 4. Model/Catalog Number: 00311US. The STA - Liquid Anti-Xa kits are int recall (Z-2474-2025)Diagnostica Stago, Inc.2025-08-28
STA-Liquid Anti-Xa 8. Model/Catalog Number: 00322US. The STA - Liquid Anti-Xa kits are int recall (Z-2475-2025)Diagnostica Stago, Inc.2025-08-28
Stago IVD, Liquid Anti-Xa, NDC 3607450003116. The STA - Liquid Anti-Xa kits are intended f recall (Z-2650-2014)Diagnostica Stago, Inc.2014-09-16