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ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS

FDA 510(k) clearance K080485 · decided 2008-12-04

Clearance details

K-number
K080485
Device name
ASPARTATE AMINO TRANSFERASE (AST/SGOT) TEST SYSTEM, ASAT (GOT) FS
Applicant
Diasys Diagnostics Systems GmbH
Decision
Substantially Equivalent
Date received
2008-02-22
Decision date
2008-12-04
Days to decision
286 days
Clearance type
Traditional
Product code
CIT
Device class
2
Regulation number
862.1100
Medical specialty
Clinical Chemistry
Advisory committee
Clinical Chemistry
Location
Holzheim, Rheinland-Pfalz, DE
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.