Atlas FDA

ANTITHROMBIN III SCREEN KIT

FDA 510(k) clearance K812215 · decided 1981-09-01

Clearance details

K-number
K812215
Device name
ANTITHROMBIN III SCREEN KIT
Applicant
Pacific Hemostasis
Decision
Substantially Equivalent
Date received
1981-08-05
Decision date
1981-09-01
Days to decision
27 days
Clearance type
Traditional
Product code
JBQ
Device class
2
Regulation number
864.7060
Medical specialty
Hematology
Advisory committee
Hematology
Location
Mchenry, IL, 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.