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

Biodiagnostic Intl — Predicate Candidate Screening

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

54 daysmedian FDA review time

238 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K031296	LIQUI-HEME GLYCO A1C ASSAY	Biodiagnostic Intl	2004-10-15	541
K881430	LIQUI-SERA SERUM ALCOHOL CONTROLS	Biodiagnostic Intl	1988-07-08	94
K874459	LIQUI-SERA SPINAL FLUID CONTROL	Biodiagnostic Intl	1987-12-29	61
K863849	LIQUI-SERA COMBO LIGAND/TDM CONTROLS	Biodiagnostic Intl	1986-11-24	55
K853906	LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)	Biodiagnostic Intl	1985-10-04	14
K853887	LIQUI-SERA CHEM. MULTIPLE CALIBRATORS	Biodiagnostic Intl	1985-09-30	11
K842668	LIQUI-HEME HEMOGLOBIN CALIBRATORS	Biodiagnostic Intl	1985-03-05	238
K840618	LIQUI-URA CHEMISTRY URINE CONTROLS	Biodiagnostic Intl	1984-04-04	50
K834398	LIQUI-SERA TDM CALIBRATORS	Biodiagnostic Intl	1984-02-03	51
K834259	LIQUI-URA TOXIC URINE CONTROL	Biodiagnostic Intl	1984-01-30	54
K831278	LIQUI-SERA ANTICONVULSANTS CONTROLS	Biodiagnostic Intl	1983-05-27	38

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