Atlas FDA

BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2

FDA 510(k) clearance K083175 · decided 2009-01-26

Clearance details

K-number
K083175
Device name
BERICHROM HEPARIN UF CALIBRATOR, BERICHROM HEPARIN UF CONTROL 1, AND BERICHROM HEPARIN UF CONTROL 2
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2008-10-28
Decision date
2009-01-26
Days to decision
90 days
Clearance type
Traditional
Product code
JPA
Device class
2
Regulation number
864.5425
Medical specialty
Hematology
Advisory committee
Hematology
Location
Newark, DE, US
Third-party review
No
Expedited review
No

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Recalls involving this device

No recalls on record reference this clearance.

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