Atlas FDA

ACL TOP 700 LAS

FDA 510(k) clearance K091980 · decided 2009-09-22

Clearance details

K-number
K091980
Device name
ACL TOP 700 LAS
Applicant
Instrumentation Laboratory CO
Decision
Substantially Equivalent
Date received
2009-07-01
Decision date
2009-09-22
Days to decision
83 days
Clearance type
Special
Product code
GKP
Device class
2
Regulation number
864.5400
Medical specialty
Hematology
Advisory committee
Hematology
Location
Bedford, MA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
ACL TOP (Base), automated coagulation laboratory instrument. recall (Z-2060-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 700, automated coagulation laboratory instrument. recall (Z-2061-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP CTS, automated coagulation laboratory instrument. recall (Z-2062-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 700 LAS, automated coagulation laboratory instrument. recall (Z-2063-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 500 CTS, automated coagulation laboratory instrument. recall (Z-2064-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 700 CTS, automated coagulation laboratory instrument. recall (Z-2065-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP 300 CTS, automated coagulation laboratory instrument. recall (Z-2066-2014)Instrumentation Laboratory Co.2014-07-16
ACL TOP (Base); PN 0000280000 Bench top, fully automated, random access analyzer designed recall (Z-2244-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 700; PN 0000280010 Bench top, fully automated, random access analyzer designed spe recall (Z-2245-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP CTS; PN 0000280020 Bench top, fully automated, random access analyzer designed spe recall (Z-2246-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 700 LAS; PN 0000280030 Bench top, fully automated, random access analyzer designed recall (Z-2247-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 700 CTS; PN 0000280050 Bench top, fully automated, random access analyzer designed recall (Z-2248-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 300 and ACL TOP 300 CTS (Japan); PN 0000280060 Bench top, fully automated, random recall (Z-2249-2013)Instrumentation Laboratory Co.2013-09-18
ACL TOP 500 CTS; PN 0000280040 Bench top, fully automated, random access analyzer designed recall (Z-2250-2013)Instrumentation Laboratory Co.2013-09-18
Instrumentation Laboratory ACL TOP (Base) PN 0000280000 ACL TOP is a bench top, fully auto recall (Z-2387-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 700 PN 0000280010 ACL TOP is a bench top, fully automat recall (Z-2388-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP CTS PN 0000280020 ACL TOP is a bench top, fully automat recall (Z-2389-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 700 LAS PN 0000280030 ACL TOP is a bench top, fully aut recall (Z-2390-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 500 CTS PN 0000280040 ACL TOP is a bench top, fully aut recall (Z-2391-2012)Instrumentation Laboratory Co.2012-09-14
Instrumentation Laboratory ACL TOP 700 CTS PN 0000280050 ACL TOP is a bench top, fully aut recall (Z-2392-2012)Instrumentation Laboratory Co.2012-09-14
ACL TOP (Base) PN 000280000 Bench top, fully automated, random access analyzer designed sp recall (Z-0135-2011)Instrumentation Laboratory Co.2010-10-25
ACL TOP 500 CTS PN 000280040 Bench top, fully automated, random access analyzer designed s recall (Z-0136-2011)Instrumentation Laboratory Co.2010-10-25
ACL TOP 700 LAS PN 000280030 Bench top, fully automated, random access analyzer designed s recall (Z-0137-2011)Instrumentation Laboratory Co.2010-10-25
ACL TOP CTS PN 000280020 Bench top, fully automated, random access analyzer designed speci recall (Z-0138-2011)Instrumentation Laboratory Co.2010-10-25