Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

LET · Predicate Candidate Screening

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

45 daysmedian FDA review time
71 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K901537MODIFIED OPUS PHENOBARBITAL TEST SYSTEMPb Diagnostic Systems, Inc.1990-06-12710
K865000IMMPULSE COATED TUBE PHENOBARBITAL ASSAY REAGENTSSclavo, Inc.1987-02-06460
K842592AMES TDA PHENOBARBITAL TESTMiles Laboratories, Inc.1984-08-17450
K830701STRATUS PHENOBARBITAL FLUOROMETRIC ENZAmerican Dade1983-05-13670
K821408PHENOBARBITAL FLUORESCENT IMMUNOAmerican Diagnostic Corp.1982-05-24130
K820188PHENOBARBITAL ASSAYSyva Co.1982-02-05110
K810994AMES TDA TM PHENOBARBITAL TESTMiles Laboratories, Inc.1981-04-29160
K802255AMES TDA PHENOBARBITAL TESTMiles Laboratories, Inc.1980-09-26100

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