Atlas FDA

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

Radioassay Systems Laboratories, Inc. — Predicate Candidate Screening

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

37 daysmedian FDA review time
62 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K862204RSL (125I) ALDOSTERONE KITRadioassay Systems Laboratories, Inc.1986-09-251070
K842960ANDROSTENEDIONE BY RIARadioassay Systems Laboratories, Inc.1984-09-27620
K840886HYDROXYPROGESTERONE BY RIA 17ARadioassay Systems Laboratories, Inc.1984-04-18510
K831855HATCH KITRadioassay Systems Laboratories, Inc.1983-07-28490
K802195DEHYDROEPIANDROSTERONE SULFATE KIT RIARadioassay Systems Laboratories, Inc.1980-10-23430
K800126RSL (125 L) PROGESTERONE KITRadioassay Systems Laboratories, Inc.1980-02-13260
K791999(125I) TESTOSTERONE KITRadioassay Systems Laboratories, Inc.1979-10-30250
K791728RSL'S ASSAY PROCEDURE QUANTITATIONRadioassay Systems Laboratories, Inc.1979-09-27280
K791740SERUM 11-DESOXYCORTISOL I AS TRACERRadioassay Systems Laboratories, Inc.1979-09-27170
K791652ESTRADIOL KIT BY RIARadioassay Systems Laboratories, Inc.1979-09-27370
K791651TOTAL ESTROGENS KIT BY RIARadioassay Systems Laboratories, Inc.1979-09-27370
K791835CORALENT COAT 125I CORTISOL RADIOIMM.Radioassay Systems Laboratories, Inc.1979-09-27100
K781730RIA, CORTISOL KITRadioassay Systems Laboratories, Inc.1978-11-22400
K781487EARLY PREGNANCY DETECTION KITRadioassay Systems Laboratories, Inc.1978-10-11440
K772281RSL INSULIN KITRadioassay Systems Laboratories, Inc.1978-01-06250

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