Atlas FDA

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

LHT — Predicate Candidate Screening

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

20 daysmedian FDA review time
35 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K874303STAPHYLASE TESTOxoid U.S.A., Inc.1987-11-06170
K863025SERO-STAT R II STAPHYLOCOCCUS TESTScott Laboratories, Inc.1986-09-15350
K820531ENDO-STAPH TEICHOIC ACID ANTIBODY KITMeridian Diagnostics, Inc.1982-04-14430
K820683STAPHYLOCOCCUS LATEX AGGLUTINATION KITAmerican Scientific Products1982-04-14340
K820347ACCU-STAPHCarr-Scarborough Microbiologicals, Inc.1982-03-04240
K812434DIAGNOSTIC KITS & KIT COMPONENTSDiagnostica, Inc.1981-09-23290
K812368RAT BLOOD IN ALSEVER'S, CITRATEDDutchland Laboratories, Inc.1981-09-09200
K812374ADULT CHICKEN BLOOD IN ALSEVER'S, C., D.Dutchland Laboratories, Inc.1981-09-09200
K812376SHEEP BLOOD IN ALSEVER'S, CITR., DEFIBRDutchland Laboratories, Inc.1981-09-09200
K812367GOOSE BLOOD IN ALSEVER'S, CITRATED (ACD)Dutchland Laboratories, Inc.1981-09-09200
K812373RABBIT BLOOD IN ALSEVER'S, CITR., DEFIBRDutchland Laboratories, Inc.1981-09-09200
K812375BABY CHICK BLOOD IN ALSEVER'SDutchland Laboratories, Inc.1981-09-09200
K812372GUINEA PIG BLOOD IN ALSEVER'S, CIT., DEFDutchland Laboratories, Inc.1981-09-09200

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