Atlas FDA

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

Advanced Biomedical Methods, Inc. — Predicate Candidate Screening

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

29 daysmedian FDA review time
63 days90th percentile
21clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K945353CLARIT(TM)Advanced Biomedical Methods, Inc.1994-12-09500
K880949SINGLE REAGENT CALCIUM FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1988-04-05290
K864866RESUBMISSION OF THE KLEERZIT REAGENTAdvanced Biomedical Methods, Inc.1987-03-16950
K852784ALKALINE PHOSPHATASEAdvanced Biomedical Methods, Inc.1985-07-22210
K852783SGOT/ALT REAGENTAdvanced Biomedical Methods, Inc.1985-07-22210
K852027GGTP REAGENT/SERUM IRON/SALICYLATE DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-05-29210
K850379DIRECT BILIRUBIN FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-03-01290
K850381MAGNESIUM REAGENT FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-03-01290
K850378LDH REAGENT FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-03-01290
K850380INORGANIC PHOSPHOROUS FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-03-01290
K844241CALCIUM REAGENT FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-01-03630
K844332CREATININE REAGENT FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-01-03570
K844331TOTAL PROTEIN REAGENT FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-01-03570
K844243TOTAL BILIRUBIN FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-01-03630
K844330ALBUMIN REAGENT FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-01-03570
K844242CHOLESTEROL REAGENT FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1985-01-03630
K844021ISE REAGENTS FOR DEMAND ANALYZERAdvanced Biomedical Methods, Inc.1984-12-10560
K771586CHOLOPAP-HDLAdvanced Biomedical Methods, Inc.1977-09-15280
K761154GLUCOSE OXIDASE REAG FOR BECKMAN ANALYZAdvanced Biomedical Methods, Inc.1976-12-09100
K761153GLUC OPAP, IN VITRO DIAG. FOR GLUCOSEAdvanced Biomedical Methods, Inc.1976-12-09100
K761152S-UREA-N, IN VITRO DIAG FOR BUNAdvanced Biomedical Methods, Inc.1976-12-09100

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