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

Utak Laboratories, Inc. — Predicate Candidate Screening

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

40 daysmedian FDA review time
141 days90th percentile
23clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K903061UTAK LABORATORIES TOXICOLOGY CONTROLUtak Laboratories, Inc.1991-04-122770
K883147TRACE ELEMENTS SERUM TOXICOLOGY CONTROLUtak Laboratories, Inc.1988-10-06720
K862419SERUM VANCOMYCIN TOXICOLOGY CONTROLUtak Laboratories, Inc.1986-11-131410
K862418BENZODIAZEPINES TOXICOLOGY CONTROLUtak Laboratories, Inc.1986-11-131410
K862421SERUM CLONAZEPAM TOXICOLOGY CONTROLUtak Laboratories, Inc.1986-11-051330
K862420UTAK-STABBS TOXICOLOGY CONTROLUtak Laboratories, Inc.1986-08-04400
K831736TRICYCLIC ANTIDEPRESSANTSUtak Laboratories, Inc.1983-07-28580
K831735MAPROTILINEUtak Laboratories, Inc.1983-07-26560
K831734AMOXAPINE 8-HYDRO-XYAMOXAPINEUtak Laboratories, Inc.1983-07-26560
K831738CAFFINE TOXICOLOGY CONTROLUtak Laboratories, Inc.1983-07-26560
K831741FLURAZEPAM TOXICOLOGY CONTROLUtak Laboratories, Inc.1983-07-26560
K831737TRICYCLIC ANTIDEPRESSNATS VIUtak Laboratories, Inc.1983-07-19490
K831739PENTOBARBITAL TOXICOLOGY CONTROLUtak Laboratories, Inc.1983-07-06360
K831740DISOPYRAMIDE N-DESALKYLDISOPYRAMIDEUtak Laboratories, Inc.1983-07-06360
K810201TOXICOLOGY CONTROLUtak Laboratories, Inc.1981-02-04120
K800888TRICYCLIC ANTIDEPRESSANTS I TX CONTROLUtak Laboratories, Inc.1980-05-02150
K800882ANTICONVULSANTS TOXICOLOGY CONTROLUtak Laboratories, Inc.1980-04-29120
K800884CARDIACS II TOXICOLOGY CONTROLUtak Laboratories, Inc.1980-04-29120
K800885BARBITURATES TOXICOLOGY CONTROLUtak Laboratories, Inc.1980-04-29120
K800886HYPNOTICS PLUS ACETAMINOPHEN TX CONTROLUtak Laboratories, Inc.1980-04-29120
K800887HYPNOTICS PLUS SALICYLATE TX CONTROLUtak Laboratories, Inc.1980-04-29120
K800883CARDIACS I TOXICOLOGY CONTROLUtak Laboratories, Inc.1980-04-29120
K800889TRICYCLIC ANTIDEPRESSANT II TX CONTROLUtak Laboratories, Inc.1980-04-29120

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