Atlas FDA

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

Electro-Nucleonics, Inc. — Predicate Candidate Screening

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

201 daysmedian FDA review time
253 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K893718DELTATEST (R) LIPASE IIElectro-Nucleonics, Inc.1989-09-281340
K883670SEROLOGICAL TEST KIT FOR IGG ANTI. EPSTEIN-BARR VIElectro-Nucleonics, Inc.1989-04-282530
K883281VIRGO HSV-2 IGG ELISAElectro-Nucleonics, Inc.1989-03-102190
K883282VIRGO HSV-1 IGG ELISAElectro-Nucleonics, Inc.1989-03-102190
K883427VIRGO(R) VZV-IGG ELISAElectro-Nucleonics, Inc.1989-03-102071
K883102VIRGO (R) CMV-IGG ELISAElectro-Nucleonics, Inc.1989-02-082010
K884784VIRGO(R) MICROWELL ALT ASSAYElectro-Nucleonics, Inc.1988-12-29440
K883205ALTLTS ALANINE AMINO TRANSFERASE ALTElectro-Nucleonics, Inc.1988-09-09430
K883206LACTATE DEHYDROGENASE LDHElectro-Nucleonics, Inc.1988-09-09430

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