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

Biotrol, USA, Inc. — Predicate Candidate Screening

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

43 daysmedian FDA review time
108 days90th percentile
46clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K934014VACUSOL PLUS DENTAL VACUUM LINE CLEANER/DISINFECTANTBiotrol, USA, Inc.1995-12-068410
K931141BIOTROL AMYLASE CNPG3Biotrol, USA, Inc.1993-05-26820
K921855BIOTROL BICARBONATE STANDARDSBiotrol, USA, Inc.1992-08-031080
K921677BIOTROL MAGNESIUM (MAGON)Biotrol, USA, Inc.1992-05-26480
K912795BIOTROL UIBC REAGENTBiotrol, USA, Inc.1991-08-12480
K910721BIOTROL PROTEIN MULTILEVEL STANDARDSBiotrol, USA, Inc.1991-05-06750
K905683BIOTROL LACTATE DEHYDROGENASE (L-P)Biotrol, USA, Inc.1991-03-11820
K905280BIOTROL BILIRUBIN C & T CONTROLBiotrol, USA, Inc.1991-02-04730
K894544BIOTROL RUB-E.I.A. TEST GBiotrol, USA, Inc.1989-08-30410
K891061BIOTROL CALCIUM MONOREACTIFBiotrol, USA, Inc.1989-08-101620
K891286BIOTROL CHEMISTRY URINE CONTROLBiotrol, USA, Inc.1989-04-10320
K890846BIOTROL URINE PROTEINS REAGENTBiotrol, USA, Inc.1989-03-21280
K890395BIOTROL IRON REAGENTBiotrol, USA, Inc.1989-03-08420
K890015BIOTROL CHLORIDEBiotrol, USA, Inc.1989-02-17450
K885094BIOTROL ALBUMINBiotrol, USA, Inc.1989-02-10630
K885053BIOTROL URINE PROTEINS REAGENTBiotrol, USA, Inc.1989-01-30540
K885041BIOTROL INORGANIC PHOSPHORUSBiotrol, USA, Inc.1989-01-30560
K884480BIOTROL BILIRUBIN MONOREACTIFBiotrol, USA, Inc.1988-11-29350
K883428BIOTROL URIC ACID ENZYMATIQUE TRINDERBiotrol, USA, Inc.1988-09-13290
K881742BIOTROL ALKALINE PHOSPHATASEBiotrol, USA, Inc.1988-07-08770
K882189BIOTROL TOTAL PROTEIN H.P.Biotrol, USA, Inc.1988-07-01380
K881856BIOTROL CREATININE H.P. REAGENTBiotrol, USA, Inc.1988-06-16440
K881702BIOTROL TRIGLYCERIDES ENZYMATIQUE UV H.P.Biotrol, USA, Inc.1988-05-27380
K881267BIOTROL CK MONOEACTIFBiotrol, USA, Inc.1988-05-16530
K881366BIOTROL BUN ENZYMATIQUE UV H.P.Biotrol, USA, Inc.1988-05-16460
K881311BIOTROL -GT GAMMA-GLUTAMYL TRANSFERASE (GGT) TESTBiotrol, USA, Inc.1988-04-28310
K873294BIOTROL TOXO ELISA TEST GBiotrol, USA, Inc.1988-04-122390
K873293BIOTROL TOXO ELISA TEST MBiotrol, USA, Inc.1988-04-122390
K875304BIOTROL CALIBRANT LEVEL 2Biotrol, USA, Inc.1988-02-03360
K875318BIOTROL CALIBRANT LEVEL 3Biotrol, USA, Inc.1988-02-02350
K875288BIOTROL CALIBRANT LEVEL 1Biotrol, USA, Inc.1988-02-02350
K875320BIOTROL URIC ACID ENZYMATIQUE UV H.P.Biotrol, USA, Inc.1988-02-01340
K874809REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUMBiotrol, USA, Inc.1988-01-07480
K874810REFERENCE ASSAYED CHEMISTRY CONTROL SERUMBiotrol, USA, Inc.1988-01-05430
K874941BIOTROL BICARBONATE (CO2) UV HP)Biotrol, USA, Inc.1988-01-05340
K873160BIOTROL TRIGLYCERIDES ENZYMATIQUE COLORBiotrol, USA, Inc.1987-09-08280
K872831BIOTROL ALPHA AMYLASEBiotrol, USA, Inc.1987-09-04490
K873180BIOTROL MAGNESIUM CALMAGITEBiotrol, USA, Inc.1987-09-02210
K873116MULTI ANALYTE MIXTURES, CALIBRATORSBiotrol, USA, Inc.1987-09-02230
K873118BIOTROL REFERENCEBiotrol, USA, Inc.1987-09-02230
K873117BIOTROL GLUCOSE ENZYMATIQUE COLOR REAGENTBiotrol, USA, Inc.1987-08-31210
K872785BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUMBiotrol, USA, Inc.1987-08-26430
K872777BIOTROL-33 PLUS PATHOLOGIQUE ASSAYED CHEM. CONTROLBiotrol, USA, Inc.1987-08-26430
K872930BIOTROL CHOLESTEROL ENZYMATIQUE COLORBiotrol, USA, Inc.1987-08-21250
K872830BIOTROL ALT/TGP MONOREACTIFBiotrol, USA, Inc.1987-08-13270
K872829BIOTROL AST/TGO MONOREACTIFBiotrol, USA, Inc.1987-08-13270

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