Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
International Enzymes, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
100 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011169 | HSCRP CONTROL LEVEL 1, HSCRP CONTROL LEVEL 2, AND HSCRP CONT | International Enzymes, Inc. | 2001-05-18 | 31 | 0 |
| K963085 | LIQUID IMMUNOLOGY CONTROL LEVEL I, II, III | International Enzymes, Inc. | 1996-08-20 | 12 | 0 |
| K953926 | LINICAL PROTEIN III CALIBRATION VERIFIERS LEVELS A-E FOR BEC | International Enzymes, Inc. | 1995-09-15 | 31 | 0 |
| K953927 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E FOR BECK | International Enzymes, Inc. | 1995-09-15 | 31 | 0 |
| K950802 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - FOR BECKM | International Enzymes, Inc. | 1995-06-01 | 100 | 0 |
| K944486 | LINICAL PROTEIN I CALIBRATION VERIFIERS LEVELS A - E | International Enzymes, Inc. | 1994-12-02 | 80 | 0 |
| K944513 | LINICAL PROTEIN VI CALIBRATION VERIFIERS LEVELS A-E | International Enzymes, Inc. | 1994-12-02 | 78 | 0 |
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