Atlas FDA

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

Microchemical Specialities, Co. — Predicate Candidate Screening

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

15 daysmedian FDA review time
103 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K823198RAPID PRESUMPTIVE IDENT. GPA STREPMicrochemical Specialities, Co.1982-11-16210
K821992ALPHA-TOXIN DISCSMicrochemical Specialities, Co.1982-10-181030
K811853PHOLPHORYL-ASE TUBESMicrochemical Specialities, Co.1981-07-16150
K811852REDUCT-ASE TUBESMicrochemical Specialities, Co.1981-07-16150
K811854GALACTOSID-ASE TUBESMicrochemical Specialities, Co.1981-07-16150
K801915ENZYME-ASE I TUBESMicrochemical Specialities, Co.1980-08-2090
K801916ORNITH-ASE TUBESMicrochemical Specialities, Co.1980-08-2090
K800816HIPPUR-ASE TUBESMicrochemical Specialities, Co.1980-07-08880
K800579BETA-ASE TUBESMicrochemical Specialities, Co.1980-04-08250

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