VARELISA SSDNA ANTIBODIES, MODEL 14896— 510(k) K040811
Substantially EquivalentPharmacia Deutschland GmbH
FDA 510(k) clearance K040811 for VARELISA SSDNA ANTIBODIES, MODEL 14896, Substantially Equivalent on 2004-05-13. Applicant: Pharmacia Deutschland GmbH. Device class: 2.
Clearance details
- Applicant
- Pharmacia Deutschland GmbH
- Product code
- Code LRM
- Device class
- Class 2
- Regulation
- 21 CFR 866.5100
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, DE
Recent devices under product code LRM
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view all- K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
- K040810 — VARELISA HISTONE ANTIBODIES, MODEL 16496
- K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
- K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
- K040451 — VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND 18896
Data sourced from openFDA. This site is unofficial and independent of the FDA.