Atlas FDA

DADE ANTITHROMBIN III CHROMOGENIC ASSAY

FDA 510(k) clearance K880315 · decided 1988-03-16

Clearance details

K-number
K880315
Device name
DADE ANTITHROMBIN III CHROMOGENIC ASSAY
Applicant
Baxter Healthcare Corp
Decision
Substantially Equivalent
Date received
1988-01-26
Decision date
1988-03-16
Days to decision
50 days
Clearance type
Traditional
Product code
JBQ
Device class
2
Regulation number
864.7060
Medical specialty
Hematology
Advisory committee
Hematology
Location
Miami, FL, US
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
INNOVANCE Antithrombin (K242952)Siemens Healthcare Diagnostic Products GmbH2025-03-28
INNOVANCE ANTITHROMBIN WITH MODELS OPFH03, OPFHO5 (K081769)Siemens Healthcare Diagnostics2009-05-28
HEMOSIL ANTITHROMBIN (K070301)Instrumentation Laboratory CO2007-02-23
HEMOSIL LIQUID ANTITHROMBIN (K062431)Instrumentation Laboratory CO2006-09-01
BIOPHEN ANTITHROMBIN 2.5, REFERENCE # 221102; BIOPHEN ANTITHROMBIN 5, REFERENCE # 221105 (K043007)Hyphen Biomed2005-11-07
HEMOSIL LIQUID ANTITHROMBIN XL (K033775)Instrumentation Laboratory CO2004-01-02
CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (K023991)Precision Biologic2003-04-28
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

Recalls involving this device

No recalls on record reference this clearance.

PMA approvals by this applicant

RecordFirmDate
Floseal Hemostatic Matrix, Floseal with Recothrom; Floseal Hemostatic Matrix, Floseal Fast Prep; 3 Floseal Hemostatic Ma (P990009/S077)Baxter Healthcare Corp2025-11-13
FLOSEAL MATRIX/FLOSEAL MATRIX HEMOSTATIC SEALANT/PROCEED HEMOSTATIC SEALANT (P990009/S076)Baxter Healthcare Corp2025-06-30
Floseal Hemostatic Matrix (P990009/S075)Baxter Healthcare Corp2025-01-30
Adept Adhesion Reduction Solution (P050011/S009)Baxter Healthcare Corp2024-08-23
Floseal Hemostatic Matrix, Floseal with Recothrom, Floseal Hemostatic Matrix, Floseal Fast Prep (P990009/S074)Baxter Healthcare Corp2024-08-15
Floseal Hemostatic Matrix (P990009/S073)Baxter Healthcare Corp2024-01-10
Floseal Hemostatic Matrix, Fast Prep, Floseal Hemostatic Matrix, RTS (P990009/S072)Baxter Healthcare Corp2023-12-12
Floseal Hemostatic Matrix, RT5 (P990009/S070)Baxter Healthcare Corp2023-02-02