VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796— 510(k) K020757
Substantially EquivalentPharmacia Deutschland GmbH
FDA 510(k) clearance K020757 for VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796, Substantially Equivalent on 2002-05-02. Applicant: Pharmacia Deutschland GmbH. Device class: 2.
Clearance details
- Applicant
- Pharmacia Deutschland GmbH
- Product code
- Code MID
- Device class
- Class 2
- Regulation
- 21 CFR 866.5660
- Advisory panel
- Immunology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Freiburg, DE
Recent devices under product code MID
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view all- K041043 — VARELISA PR3 ANCA, MODEL NUMBER 17748/17796
- K040810 — VARELISA HISTONE ANTIBODIES, MODEL 16496
- K040811 — VARELISA SSDNA ANTIBODIES, MODEL 14896
- K040449 — VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND 18796
- K040450 — VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND 18996
Data sourced from openFDA. This site is unofficial and independent of the FDA.