Atlas FDA

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

Biokit USA, Inc. — Predicate Candidate Screening

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

67 daysmedian FDA review time
256 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K913467TOXOGENBiokit USA, Inc.1993-01-115250
K910541BIOKIT RPRBiokit USA, Inc.1991-10-182560
K904310RHEUMAGEN RF T-CONTROLBiokit USA, Inc.1991-05-312540
K910539RHEUMAJET RFBiokit USA, Inc.1991-04-05670
K910686RHEUMAJET CRPBiokit USA, Inc.1991-03-19280
K904311RHEUMAGEN ASO T-CONTROLBiokit USA, Inc.1991-01-251280
K904312RHEUMAGEN CRP T-CONTROLBiokit USA, Inc.1990-10-01120
K896433MODIFIED RUBAGENBiokit USA, Inc.1989-11-29200
K896271QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL)Biokit USA, Inc.1989-11-0890
K896272QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROLBiokit USA, Inc.1989-11-0890
K894486QUANTEX ASO PLUS (LATEX,BUFFER STANDARD,CONTROL)Biokit USA, Inc.1989-10-24980
K893755RUBAGENBiokit USA, Inc.1989-08-21940
K874678I.M.N. LATEXBiokit USA, Inc.1987-12-14310
K854991REUMAGEN ASLBiokit USA, Inc.1986-04-181270
K843741RPR TEST REDITESTBiokit USA, Inc.1984-10-25300
K842256AS LATEX PLUSBiokit USA, Inc.1984-06-19120

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