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

Gilford Diagnostics — Predicate Candidate Screening

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

25 daysmedian FDA review time

49 days90th percentile

50clearances measured

K-number	Device	Applicant	Decided	Review days
K832094	BILIRUBIN CALIBRATORS & CONTROL	Gilford Diagnostics	1983-08-11	44
K831843	GILCHEM TOTAL BILIRUBIN REAGENT	Gilford Diagnostics	1983-07-18	40
K831844	DIRECT BILIRUBIN REAGENT	Gilford Diagnostics	1983-07-18	40
K823709	TRIGLYCERIDE REAGENT (UV)	Gilford Diagnostics	1983-01-07	29
K822739	AHBD	Gilford Diagnostics	1982-10-18	39
K822334	BILIRUBIN CALIBRATORS	Gilford Diagnostics	1982-09-02	29
K822289	CO2/CI STANDARDS	Gilford Diagnostics	1982-08-24	22
K822149	GILCHEM Y-GT REAGENT	Gilford Diagnostics	1982-08-12	21
K821719	AMMONIA REAGENT	Gilford Diagnostics	1982-06-24	14
K820975	GILCHEM ACID PHOSPHATASE REAGENT	Gilford Diagnostics	1982-04-26	20
K820976	GIL CHEM MAGNESIUM REAGENT	Gilford Diagnostics	1982-04-26	20
K813478	TRIGLYCERIDE CALIBRATORS	Gilford Diagnostics	1981-12-22	21
K812912	GILCHEM ALP REAGENT	Gilford Diagnostics	1981-11-02	14
K812861	CHOLESTEROL CALIBRATORS	Gilford Diagnostics	1981-10-23	10
K812110	GILCHEM CALCIUM REAGENT	Gilford Diagnostics	1981-08-13	17
K812109	GILCHEM CREATININE REAGENT	Gilford Diagnostics	1981-08-13	17
K811886	CESIUM DILUENT 7.5M	Gilford Diagnostics	1981-07-23	22
K811659	CREATININE REAGENT	Gilford Diagnostics	1981-06-26	14
K810405	CHOLESTEROL REAGENT	Gilford Diagnostics	1981-02-26	8
K803301	CREATINE KINASE REAGENT	Gilford Diagnostics	1981-01-16	17
K802633	BUN/GLUCOSE STANDARDS	Gilford Diagnostics	1980-12-11	49
K802632	ALBUMIN/TOTAL PROTEIN STANDARDS	Gilford Diagnostics	1980-12-11	49
K802631	CREATININE STANDARDS	Gilford Diagnostics	1980-12-11	49
K801600	GLUCOSE (TRINDER) REAGENT	Gilford Diagnostics	1980-08-27	44
K800996	HDL REAGENT	Gilford Diagnostics	1980-05-14	19
K801012	TRIGLYCERIDE REAGENT (COLOR)	Gilford Diagnostics	1980-05-14	16
K800341	BUN REAGENT	Gilford Diagnostics	1980-03-12	26
K800120	LDH (L-P) REAGENT	Gilford Diagnostics	1980-02-13	26
K800065	ASI REAGENT	Gilford Diagnostics	1980-02-05	25
K800042	LITHIUM STANDARD (1MM/L)	Gilford Diagnostics	1980-01-21	14
K800038	ALT REAGENT	Gilford Diagnostics	1980-01-21	14
K800043	CESIUM DILUENT (1.5 MM/L)	Gilford Diagnostics	1980-01-21	14
K800041	SODIUM/POTASSIUM 140/5 MEQ/L)	Gilford Diagnostics	1980-01-21	14
K800039	LITHIUM DILUENT (1500 MM/E)	Gilford Diagnostics	1980-01-21	14
K800040	SODIUM/POTASSIUM (100/100 MEQ/E)	Gilford Diagnostics	1980-01-21	14
K792605	CHLORIDE REAGENT	Gilford Diagnostics	1980-01-16	29
K792046	URIC ACID STANDARD	Gilford Diagnostics	1979-10-30	18
K791874	CALCIUM/PHOSPHORUS/MAGNESIUM STANDARD	Gilford Diagnostics	1979-10-17	26
K791725	CHOLINESTERASE REAGENT	Gilford Diagnostics	1979-10-17	47
K791754	URIC ACID REAGENT	Gilford Diagnostics	1979-09-27	22
K791708	INORGANIC PHOSPHORUS REAGENT	Gilford Diagnostics	1979-09-24	27
K791213	GLUCOSE (GDH) REAGENT	Gilford Diagnostics	1979-08-10	39
K790786	GLUCOSE (HK) REAGENT	Gilford Diagnostics	1979-06-15	53
K790771	LD-P REAGENT (LDH P-L REAGENT)	Gilford Diagnostics	1979-05-15	25
K781782	BUN	Gilford Diagnostics	1979-01-10	83
K781784	AST	Gilford Diagnostics	1979-01-03	76
K781783	BLOOD SUGAR	Gilford Diagnostics	1978-12-04	46
K781774	TOTAL PROTEIN	Gilford Diagnostics	1978-11-22	40
K781773	ALBUMIN REAGENT	Gilford Diagnostics	1978-11-22	40
K781775	LDH	Gilford Diagnostics	1978-11-22	40

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