Atlas FDA

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

Orgentec — Predicate Candidate Screening

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

181 daysmedian FDA review time
201 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954831ORGENTEC ANTI-RNP/SM PIN IMMUNO ASSAYOrgentec1996-05-082010
K954830ORGENTEC ANTI-SM(SMITH) PIN IMMUNO ASSAYOrgentec1996-05-082010
K954814ORGENTEC ANTI-SCL 70 PIN IMMUNO ASSAYOrgentec1996-04-181820
K954829ORGENTEC ANTI-JO-1 PIN IMMUNO ASSAYOrgentec1996-04-181810
K954815ORGENTEC ANTI-SS-A(RO) PIN IMMUNO ASSAYOrgentec1996-04-181820
K954832ORGENTEC ANTI-SS-B(LA) PIN IMMUNO ASSAYOrgentec1996-04-181810
K960274ORGENTEC MICRO-ALBUMIN PIN EIA ASSAYOrgentec1996-03-29700
K955134ORGENTEC ENASCREEN ELISA ASSAYOrgentec1996-03-201320
K955133ORGENTEC ENASCREEN PIN IMMUNO ASSAYOrgentec1996-03-201320
K953671ORGEN TEC ANTI-DSDNA ELISA ASSAYOrgentec1995-11-09940

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