Atlas FDA

ACTICHROME ATIII KIT

FDA 510(k) clearance K893608 · decided 1989-06-23

Clearance details

K-number
K893608
Device name
ACTICHROME ATIII KIT
Applicant
American Diagnostic Corp.
Decision
Substantially Equivalent
Date received
1989-05-10
Decision date
1989-06-23
Days to decision
44 days
Clearance type
Traditional
Product code
JBQ
Device class
2
Regulation number
864.7060
Medical specialty
Hematology
Advisory committee
Hematology
Location
New York, NY, US
Third-party review
No
Expedited review
No

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CHROMOCHECK ANTITHROMBIN 25; CHROMOCHECK ANTITHROMBIN 50 (K023991)Precision Biologic2003-04-28
COAMATIC LR ANTITHROMBIN, NOTE: LR=LIQUID REAGENTS (K022550)Instrumentation Laboratory CO2002-08-27
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IL TEST LIQUID ANTITHROMBIN (K994238)Instrumentation Laboratory CO2000-06-23
K-ASSAY AT-III (K000361)Kamiya Biomedical Co.2000-04-26
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Recalls involving this device

No recalls on record reference this clearance.