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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Pharmacia Deutschland GmbH · Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

71 daysmedian FDA review time
81 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041043VARELISA PR3 ANCA, MODEL NUMBER 17748/17796Pharmacia Deutschland GmbH2004-07-02710
K040810VARELISA HISTONE ANTIBODIES, MODEL 16496Pharmacia Deutschland GmbH2004-05-14460
K040811VARELISA SSDNA ANTIBODIES, MODEL 14896Pharmacia Deutschland GmbH2004-05-13450
K040451VARELISA B2 GLYCOPROTEIN I IGM ANTIBODIES, MODELS 18848 AND Pharmacia Deutschland GmbH2004-05-11810
K040449VARELISA B2 GLYCOPROTEIN I IGG ANTIBODIES, MODELS 18748 AND Pharmacia Deutschland GmbH2004-05-11810
K040450VARELISA B2 GLYCOPROTEIN I IGA ANTIBODIES, MODELS 18948 AND Pharmacia Deutschland GmbH2004-05-11810
K040452VARELISA B2 GLYCOPROTEIN I ANTIBODIES SCREEN, MODELS 19048 APharmacia Deutschland GmbH2004-05-11810
K020752VARELISA CARDIOLIPIN IGG ANTIBODIES, MODELS 15548 & 15596Pharmacia Deutschland GmbH2002-05-02560
K020757VARELISA CARDIOLIPIN IGA ANTIBODIES, MODELS 15748 & 15796Pharmacia Deutschland GmbH2002-05-02560
K020758VARELISA CARDIOLIPIN IGM ANTIBODIES, MODELS 15648 & 15696Pharmacia Deutschland GmbH2002-05-02561

Methodology

Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.

Prepared with Atlas

Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda