Atlas FDA

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

Analytical & Research Chemicals, Inc. — Predicate Candidate Screening

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

34 daysmedian FDA review time
50 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823806DIRECT CREATININE PROCEDUREAnalytical & Research Chemicals, Inc.1983-01-14290
K823786ALKALINE PHOSPHATASEAnalytical & Research Chemicals, Inc.1983-01-14290
K823784ENZYMATIC CHOLESTEROL (COLORIMETRICAnalytical & Research Chemicals, Inc.1983-01-14290
K781441BCG ALBUMIN REAGETAnalytical & Research Chemicals, Inc.1978-10-10500
K781460CHLORIDE REAGENTAnalytical & Research Chemicals, Inc.1978-10-10500
K781323LDH PROCEDUREAnalytical & Research Chemicals, Inc.1978-08-31310
K781308GLUCOLOURAnalytical & Research Chemicals, Inc.1978-08-31340
K781324ALP TESTAnalytical & Research Chemicals, Inc.1978-08-31310
K781309GOT PROCEDUREAnalytical & Research Chemicals, Inc.1978-08-31340
K781305UREA NITROGENAnalytical & Research Chemicals, Inc.1978-08-31340
K781306UREA NITROGEN TEST KITAnalytical & Research Chemicals, Inc.1978-08-31340
K781307GLUCOSE DETERM. KITAnalytical & Research Chemicals, Inc.1978-08-31340

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