Atlas FDA

IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM

FDA 510(k) clearance K091361 · decided 2009-12-16

Clearance details

K-number
K091361
Device name
IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM
Applicant
Siemens Healthcare Diagnostics
Decision
Substantially Equivalent
Date received
2009-05-08
Decision date
2009-12-16
Days to decision
222 days
Clearance type
Traditional
Product code
LIP
Device class
2
Regulation number
866.3830
Medical specialty
Microbiology
Advisory committee
Microbiology
Location
Suwanee, GA, US
Third-party review
No
Expedited review
No

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Recalls involving this device

RecordFirmDate
Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, recall (Z-2965-2026)Siemens Healthcare Diagnostics Products Ltd.2026-08-14
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