IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM— 510(k) K091361
Substantially EquivalentSiemens Healthcare Diagnostics
FDA 510(k) clearance K091361 for IMMULITE 2000 SYPHILIS SCREEN TEST SYSTEM, Substantially Equivalent on 2009-12-16. Applicant: Siemens Healthcare Diagnostics. Device class: 2.
Clearance details
- Applicant
- Siemens Healthcare Diagnostics
- Product code
- Code LIP
- Device class
- Class 2
- Regulation
- 21 CFR 866.3830
- Advisory panel
- Microbiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Suwanee, GA, US
Recent devices under product code LIP
view allMore clearances from Siemens Healthcare Diagnostics
view all- K243570 — Dimension LOCI Thyroid Stimulating Hormone Flex reagent cartridge (TSHL) +1 more
- K162977 — ADVIA 2120i, ADVIA 2120
- K162298 — LOCI Total Vitamin D Total Assay, LOCI VITD CAL
- K161954 — Atellica Solution, Atellica A-LYTE Integrated Multisensor Na+/K+/CI-, Atellica CH Albumin BCP Reagent (Alb_p), Atellica IM Thyroid Stimulating Hormone TSH, Atellica CH Vancomycin (Vanc)
- K162538 — ADVIA Centaur Insulin (IRI) Master Curve Material (MCM), ADVIA Centaur (IRI) Calibrator
Recalls naming K091361
K-number listed on FDA's recall record- Z-2965-2026 — Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF:L2KSY2(D)/10471981 IVD, RxOnly
- Z-2966-2026 — Siemens Healthineers Immulite 2000 Systems SYP Syphilis Screen REF(s):L2kSY2/10489085; L2KSY6/10488319 IVD, RxOnly
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K091361.
Data sourced from openFDA. This site is unofficial and independent of the FDA.