Atlas FDA

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

LGR — Predicate Candidate Screening

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

58 daysmedian FDA review time
126 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K955873ACS PHENYTOIN ASSAYCiba Corning Diagnostics Corp.1996-03-11760
K955562INNOFLUOR PHENYTOIN ASSAY SYSTEMOxis Intl., Inc.1996-01-24490
K953840AXSYM PHENYTOIN IIAbbott Laboratories1995-09-25400
K946328TDX(R)/TDXFLX(R) PHENYTOIN IIAbbott Laboratories1995-03-28890
K943313PHENYTOIN FPIA REAGENT SET AND CALIBRATORSSigma Diagnostics, Inc.1994-10-271080
K935375AXSYM PHENYTOIN ASSAYAbbott Laboratories1994-06-212250
K936131COBAS-FP REAGENT FOR PHENYTOIN AND COBA-FP PHENYTOIN CALIBRARoche Diagnostic Systems, Inc.1994-03-11780
K896868OPUS PHENYTOIN TEST SYSTEMPb Diagnostic Systems, Inc.1990-01-02260
K895827INNOFLUOR PHENYTOIN MANUAL FPIA REAGENT SETInnotron of Oregon, Inc.1989-10-31290
K872563INNOTRON INNOFLUOR PHEYTOIN REAGENT SETInnotron of Oregon, Inc.1987-08-21580
K862554IMMPULSE PHENYTOIN ASSAY REAGENTSclavo, Inc.1986-07-16130
K843824COBAS FP REAGENTS FOR PHENYTOIN & CALIBRRoche Diagnostic Systems, Inc.1985-02-011260
K844171PHENYTOIN RADIOIMMUNOASSAY USING THE ARIA HT SYSTEBd Becton Dickinson Vacutainer Systems Preanalytic1984-12-10460
K842586PHENYTOIN KIT FLUORESCENCE POLARIZATIONWindsor Laboratories, Inc.1984-09-26850
K841706INNOFLUOR PHENYTOINInnotron Diagnostics1984-05-22290

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