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

London Diagnostics, Inc. · Predicate Candidate Screening

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

52 daysmedian FDA review time

70 days90th percentile

12clearances measured

K-number	Device	Applicant	Decided	Review days
K914835	LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY	London Diagnostics, Inc.	1991-12-17	53
K911985	LUMATAG T4 CHEMILUMINESCENCE ASSAY	London Diagnostics, Inc.	1991-08-02	88
K912858	LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY	London Diagnostics, Inc.	1991-07-30	32
K905814	LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY	London Diagnostics, Inc.	1991-02-04	38
K904458	LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION	London Diagnostics, Inc.	1990-10-12	11
K903130	LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY	London Diagnostics, Inc.	1990-09-25	70
K903195	LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY	London Diagnostics, Inc.	1990-08-02	14
K902443	LUMATAG(TM) LH DIAGNOSTIC KIT	London Diagnostics, Inc.	1990-08-02	62
K901484	LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC	London Diagnostics, Inc.	1990-05-01	33
K901075	LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET.	London Diagnostics, Inc.	1990-04-02	25
K881443	LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY	London Diagnostics, Inc.	1988-05-27	52
K880296	LUMATAG(TM) PROLACTIN CHEMILUMINES. IMMUNO. ASSAY	London Diagnostics, Inc.	1988-03-24	59

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