Atlas FDA

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

Syva Co., Dade Behring, Inc. — Predicate Candidate Screening

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

24 daysmedian FDA review time
33 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K011920EMIT 2000 DIGOXIN ASSAY, MODEL OSR4H229Syva Co., Dade Behring, Inc.2001-07-02120
K011620EMIT 2000 N-ACETYLPROCAINAMIDE ASSAY, MODEL OSR4N229Syva Co., Dade Behring, Inc.2001-06-18240
K011605EMIT 2000 QUINIDINE ASSAY, MODEL OSR4Q229Syva Co., Dade Behring, Inc.2001-06-12190
K011300EMIT II PLUS CANNABINOID ASSAY, MODEL OSR9N229Syva Co., Dade Behring, Inc.2001-05-17170
K011306EMIT II PLUS BENZODIAZEPINE ASSAY, MODEL 0SR9F229Syva Co., Dade Behring, Inc.2001-05-16160
K011161MODIFICATION TO THE EMIT II PLUS PHENCYCLIDINE ASSAY, MODEL Syva Co., Dade Behring, Inc.2001-05-15290
K011289EMIT II PLUS OPIATE ASSAY, MODEL OSR9B229Syva Co., Dade Behring, Inc.2001-05-15180
K011166MODIFICATION TO EMIT 2000 THEOPHYLLINE ASSAY, MODEL OSR 4P22Syva Co., Dade Behring, Inc.2001-05-10240
K011163MODIFICATION TO THE EMIT II PLUS PROPOXYPHENE ASSAY, MODEL OSyva Co., Dade Behring, Inc.2001-05-10240
K011164MODIFICATION TO THE EMIT II PLUS METHAQUALONE ASSAY, MODEL OSyva Co., Dade Behring, Inc.2001-05-10240
K011162MODIFICATION TO THE EMIT II PLUS COCAINE METABOLITE ASSAYSyva Co., Dade Behring, Inc.2001-05-02160
K010960EMIT II PLUS ETHYL ALCOHOL ASSAY, MODEL OSR9K229Syva Co., Dade Behring, Inc.2001-04-26270
K010962EMIT II PLUS METHADONE ASSAY, MODEL OSRE229Syva Co., Dade Behring, Inc.2001-04-26270
K010934EMIT II PLUS BARBITUATE ASSAY, MODEL 0SR9D0229Syva Co., Dade Behring, Inc.2001-04-20230
K010984EMIT 2000 GENTAMICIN PLUS ASSAYSyva Co., Dade Behring, Inc.2001-04-20180
K010812EMIT 2000 PROCAINAMIDE ASSAY, MODEL OSR4K229Syva Co., Dade Behring, Inc.2001-04-13250
K010814EMIT 2000 CARBAMAZEPINE ASSAY, MODEL OSR4F229Syva Co., Dade Behring, Inc.2001-04-13250
K003341EMIT 2000 TOBRAMYCIN ASSAY EMIT 2000 TOBRAMYCIN CALIBRATORSSyva Co., Dade Behring, Inc.2001-01-22890
K000600SYVA EMIT 2000 THYROXINE ASSAY, CALIBRATORSSyva Co., Dade Behring, Inc.2000-03-27330

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