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

Alko Diagnostic Corp. — Predicate Candidate Screening

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

78 daysmedian FDA review time

359 days90th percentile

31clearances measured

K-number	Device	Applicant	Decided	Review days
K001484	CALIBRATION SOLUTION 1, MODEL A943-837; CALIBRATION SOLUTION	Alko Diagnostic Corp.	2000-06-19	39
K982501	ELECTROLYTE BUFFER A443-325, ELECTROLYTE REFERENCE REAGENT A	Alko Diagnostic Corp.	1998-09-01	43
K972004	ISE REAGENTS FOR OLYMPUS AU 800/AU5200 CHEMISTRY SYSTEMS	Alko Diagnostic Corp.	1997-06-16	17
K970921	STANDARD A MULTIPLY (A540-0), STANDARD B MULTIPLY (A550-0),	Alko Diagnostic Corp.	1997-04-08	27
K962864	THB CAL STANDARD FOR IL CO-OXIMETERS/OXIMETERS	Alko Diagnostic Corp.	1996-12-18	148
K963734	ISE REAGENTS FOR HITACHI 700 SERIES AND 911 CLINICAL CHEMIST	Alko Diagnostic Corp.	1996-10-24	56
K960085	ISE CALIBRANT A & B, ISE LIQUID REAGENT FOR PARAMAX CLINAK S	Alko Diagnostic Corp.	1996-03-11	60
K955154	CAL 1 & CAL 2 SOLUTION, FLUSH SOLUTION KIT	Alko Diagnostic Corp.	1995-12-11	28
K951071	ALKO SLOPE THB SOLUTION FOR CORNING 280, 288 AND 2500 ANALYZ	Alko Diagnostic Corp.	1995-07-24	138
K950902	ALKO TONOMETERED SALINE CONTROL	Alko Diagnostic Corp.	1995-03-30	30
K944922	ALKO CAL PACKS FOR CORNING 654 ANALYZERS	Alko Diagnostic Corp.	1995-02-10	127
K945966	ALKO CALIBRATORS AND FLUSH SOLUTION FOR IL 1300 SERIES PH/BL	Alko Diagnostic Corp.	1995-02-10	65
K944516	FLUIDS PACK	Alko Diagnostic Corp.	1994-11-02	48
K940760	FLUIDS PACK FOR CORING 238	Alko Diagnostic Corp.	1994-09-06	200
K942549	ALKO FLUIDS PACKS FOR NOVA 8 ANALYZERS	Alko Diagnostic Corp.	1994-07-28	58
K934607	ALKO REAGENTS FOR BAXTER PARAMAX CHEMISTRY SYSTEM	Alko Diagnostic Corp.	1994-03-28	182
K933383	REAGENTS FOR HITACHI ISE	Alko Diagnostic Corp.	1994-03-09	270
K935018	REAGENTS FOR ORION 1020, AND RELATED ANALYZERS	Alko Diagnostic Corp.	1994-01-18	90
K935547	CAL 1 AND CAL 2 STANDARDS/STANDARDS FOR IL 501 SODIUM/POTASS	Alko Diagnostic Corp.	1994-01-18	62
K930796	ISE CALIBRATORS FOR CORNING 600 SERIES ANALYZERS	Alko Diagnostic Corp.	1994-01-13	331
K925464	CALIBRATION SOLUTIONS FOR USE ON ELECTROLYTE INSTR	Alko Diagnostic Corp.	1994-01-13	441
K930231	ALKO CALIBRATION FOR AMDEV LYTENING SYSTEMS	Alko Diagnostic Corp.	1994-01-13	359
K930199	ALKO FLUIDS PACKS FOR NOVA ANALYZERS	Alko Diagnostic Corp.	1994-01-13	364
K925385	REAGENTS FOR ABBOTT SPECTRUM/EPX (ELECTRO CALIBRA)	Alko Diagnostic Corp.	1994-01-13	444
K934701	REAGENTS FOR COBAS ISE MODULE	Alko Diagnostic Corp.	1993-12-02	63
K926518	ISE CALIBRATOR FOR DUPONT DIMENSION	Alko Diagnostic Corp.	1993-01-28	29
K915675	ELECTRODE, ION SPECIFIC	Alko Diagnostic Corp.	1992-04-29	132
K915797	CALIBRATOR	Alko Diagnostic Corp.	1992-01-30	37
K884266	PH BLOOD GAS CONTROL PRODUCTS	Alko Diagnostic Corp.	1989-05-16	217
K884267	ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS	Alko Diagnostic Corp.	1989-05-04	205
K813127	SODIUM & POTASSIUM PRODUCTS	Alko Diagnostic Corp.	1982-01-22	78

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