Atlas FDA

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

Tech Intl. Co. — Predicate Candidate Screening

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

89 daysmedian FDA review time
157 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K915704AMYLASE (KINETIC) REAGENT SETTech Intl. Co.1996-06-2816750
K915705ACID PHOSPHATASE REAGENT SETTech Intl. Co.1992-02-27900
K915707AMMONIA REAGENT SETTech Intl. Co.1992-02-26890
K914158URIC ACID REAGENT SETTech Intl. Co.1992-02-211570
K915706LIPASE REAGENT SETTech Intl. Co.1992-02-18810
K914160CHOLESTEROL REGEANT SETTech Intl. Co.1992-01-301350
K915710AMYLASE (COLORIMETRIC) REAGENT SETTech Intl. Co.1992-01-30620
K915709CREATINE KINASE-MB (CK-MB) REAGENT SETTech Intl. Co.1992-01-27590
K914159GLUCOSE REAGENT SETTech Intl. Co.1992-01-271320
K915708INORGANIC PHOSPHORUS(COLORIMETRIC) REAGENT SETTech Intl. Co.1992-01-22540
K914171IN VITRO DIAGNOSTIC REGEANT SET,CHOLINESTERASETech Intl. Co.1991-12-18920
K902495ACID PHOSPHATASE REAGENT SETTech Intl. Co.1990-07-16410
K902572SODIUM REAGENT SETTech Intl. Co.1990-07-10290

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