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

Biowhittaker Molecular Applications, Inc. — Predicate Candidate Screening

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

322 daysmedian FDA review time
737 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K943843VARICELISA, MODIFICATIONBiowhittaker Molecular Applications, Inc.1996-03-145950
K942250BIOWHITTAKER CARTRIDGE SOFTWARE FOR EIA-400 PLATE READERBiowhittaker Molecular Applications, Inc.1995-04-043300
K942361WHITSOFTBiowhittaker Molecular Applications, Inc.1995-04-043220
K942245BIOWHITTAKER 2001 MICROPLATE READER FIRMWAREBiowhittaker Molecular Applications, Inc.1995-04-033290
K925209MUMPS STATBiowhittaker Molecular Applications, Inc.1994-10-147370
K935618SPECIMEN TRANSPORT MEDIUMBiowhittaker Molecular Applications, Inc.1994-04-211500
K932679RHEUMELISA II HISTONE ANTIBODY TEST KITBiowhittaker Molecular Applications, Inc.1993-08-23820
K930757RHEUMELISA II JO-1 ANTIBODY TEST KITBiowhittaker Molecular Applications, Inc.1993-03-26420
K930130RHEUMELISA II SCL-70 ANTIBODY TEST KITBiowhittaker Molecular Applications, Inc.1993-03-23700
K920753RF STAT IGM TEST KITBiowhittaker Molecular Applications, Inc.1992-03-30400

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