Atlas FDA

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

Nordiclab Intl. — Predicate Candidate Screening

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

23 daysmedian FDA review time
38 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K801988NORDICLAB PROSTATIC ACID PHOSPHATASE RIANordiclab Intl.1980-09-26380
K801989NORDICLAB FERRITIN IRMA TESTNordiclab Intl.1980-09-16280
K800922NORDICLAB PROGESTERONE RIA TESTNordiclab Intl.1980-05-14230
K800921NORDICLAB TESTOSTERONE RIA TESTNordiclab Intl.1980-05-14230
K800920NORDICLAB ESTRADIOL RIA TESTNordiclab Intl.1980-05-14230
K792189NORDICLAB TOTAL ESTRIOL RIA TESTNordiclab Intl.1979-11-13130
K782157IRMA TEST, NORDICLAB FERRITINNordiclab Intl.1979-01-17260
K782099RIA TEST, NORDICALB HPLNordiclab Intl.1979-01-10230

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