Atlas FDA

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

Diagnostic Systems — Predicate Candidate Screening

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

28 daysmedian FDA review time
97 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K905146OLYMPUS URINE PHDiagnostic Systems1991-02-04810
K893691EMDS CREATINE KINASE ITEM NIMBER 65411Diagnostic Systems1989-08-311070
K893692EMDS ASPARTATE AMINOTRANSFERASE ITEM NUMBER 65405Diagnostic Systems1989-08-21970
K893966HDL PRECIPITATING REAGENTDiagnostic Systems1989-07-25530
K884993VISUAL BLOOD GLUCOSE TEST SYSTEMDiagnostic Systems1988-12-29280
K881116EASY-TEST EMIT(R) LIDOCAINE LIDO ITEM NO. 16641Diagnostic Systems1988-06-20970
K880787EASY-TEST LACTIC ACID (LA)Diagnostic Systems1988-03-15180
K862403EMDS ANTIEPILEPTIC DRUG CALIBRATORS ITEM #67630/95Diagnostic Systems1986-07-11150
K854784ABSORBANCE (ABS) TEST PAKDiagnostic Systems1985-12-19200
K853699EASY ANALYZER & EASY-TEST REAGENTDiagnostic Systems1985-09-25210
K853532ALCOHOL CALIBRATORSDiagnostic Systems1985-09-16240
K853533ABSORBANCE TEST SOLUTIONDiagnostic Systems1985-09-16240
K830816DSL 1900Diagnostic Systems1983-04-12280
K830700MMH PTH RIA KITDiagnostic Systems1983-04-06300

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