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

Lipogen, Inc. — Predicate Candidate Screening

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

50 daysmedian FDA review time
149 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K902636LIPOGEN RHEUMELISA DSDNA ASSAYLipogen, Inc.1990-06-28140
K895996RHEUMELISA ASSAY FOR SM AUTOANTIBODIESLipogen, Inc.1989-11-06240
K895997RHEUMELISA ASSAY FOR RNP AUTOANTIBODIESLipogen, Inc.1989-11-06240
K895995RHEUMELISA ASSAY FOR SS-B/LA AUTOANTIBODIESLipogen, Inc.1989-10-27140
K895994RHEUMELISA ASSAY FOR SS-A/RO AUTOANTIBODIESLipogen, Inc.1989-10-24110
K894659ANA ANTISERA CONTROL KITLipogen, Inc.1989-09-21590
K892421MODIFIED ACCESS R-CLONE ANA/RF SCREENING TESTLipogen, Inc.1989-05-09290
K885048ACCESS R-CLONE ANA PROFILE ASSAYLipogen, Inc.1989-01-24480
K882740ACCESS R-CLONE(TM) ANA/RF SCREENING ASSAYLipogen, Inc.1988-09-22830
K880254SM ANTIBODY TEST KITLipogen, Inc.1988-04-06770
K874195LA ANTIBODY TEST KITLipogen, Inc.1988-03-111490
K874152RNP ANTIBODY TEST KITLipogen, Inc.1988-03-111500
K875246LIPOGEN ANA TEST KITLipogen, Inc.1988-02-10500
K874151RF DIPSTICK TEST KITLipogen, Inc.1987-12-29770
K874191NDNA ANTIBODY TEST KITLipogen, Inc.1987-12-18650

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