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

Casco Standards — Predicate Candidate Screening

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

59 daysmedian FDA review time

100 days90th percentile

38clearances measured

K-number	Device	Applicant	Decided	Review days
K981436	DOCUMENT AMMONIA/ETHANOL/LACTATE CALIBRATOR, PN: M-109	Casco Standards	1998-04-24	10
K972904	DOCUMENT MOLECULAR PATHOLOGY CHLAMYDIA TRACHOMATIS CONTROL	Casco Standards	1998-02-20	198
K962629	DOCUMENT AMMONIA, ETHANOL, LACTATE CALIBRATOR	Casco Standards	1996-09-13	70
K961750	DOCUMENT CARDIAC ASSAYED CONTROL	Casco Standards	1996-07-22	77
K962630	DOCUMENT AMMONIA, ETHANOL, LACTATE ASSAYED CONTROL	Casco Standards	1996-07-22	17
K960244	DOCUMENT TDM ULTRA ASSAYED CONTROL	Casco Standards	1996-03-22	66
K955155	DOCUMENT TDM ULTRA UNASSAYED CONTROL	Casco Standards	1995-12-20	37
K950469	DOCUMENT SERUM MULTIANALYTE CALIBRATION VERIFICATION TEST SE	Casco Standards	1995-04-11	67
K945718	DOCUMENT(R) HDL CHOLESTEROL CALIBRATION VERIFICATION TEST SE	Casco Standards	1995-01-17	57
K945315	DOCUMENT(R) AMMONIA/ETHANOL AQUEOUS CONTROL	Casco Standards	1994-12-09	38
K944361	DOCUMENT R AMMONIA/ETHANOL CONTROL	Casco Standards	1994-11-30	84
K944338	DOCUMENT R AMMONIA / ETHANOL CALIBRATION VERIFICATION REST S	Casco Standards	1994-11-15	70
K944639	DOCUMENTR AMMONIA/ETHANOLCALIBRATOR	Casco Standards	1994-11-15	55
K940568	DOCUMENT(R) ZERO	Casco Standards	1994-04-05	56
K932870	DOCUMENT CHEM IV CALIBRATION VERIFICATION TEST SET	Casco Standards	1993-08-02	49
K932458	DOCUMENT ENZYME	Casco Standards	1993-06-29	39
K931139	DOCULMENT(R) CHEM VI CALIBRATION VERIF TEST SET	Casco Standards	1993-05-12	68
K924493	DOCUMENT TOTAL AND DIRECT BILIRUBIN LINEARITY-MOD	Casco Standards	1993-01-11	136
K923821	DOCUMENT CHEM V CALIBRATION VERIFICATION TEST SET	Casco Standards	1992-11-05	98
K923793	DOCUMENT CHEM III CALIBRATION VERIFICATION TEST	Casco Standards	1992-11-05	100
K923795	DOCUMENT CHEM I CALIBRATION VERIFICATION TEST SET	Casco Standards	1992-11-05	100
K923794	DOCUMENT CHEM II CALIBRATION VERIFICATION TEST SET	Casco Standards	1992-11-05	100
K915792	DOCUMENT CK ISOENZYMES CONTROL	Casco Standards	1992-02-06	44
K913309	TDM I LINEARITY TEST SET	Casco Standards	1991-09-13	50
K910440	DOCUMENT REFLECTANCE II LINEARITY TEST SET	Casco Standards	1991-05-10	99
K910962	CHOLESTEROL CALIBRATOR SET	Casco Standards	1991-03-29	23
K901988	DOCUMENT(R) REFLECTANCE I LINEARITY TEST SET	Casco Standards	1990-05-31	29
K896522	DOCUMENT(TM) TOTAL AND DIRECT BILIRUBIN LINEARITY	Casco Standards	1990-01-02	48
K893139	DOCUMENT(TM) URIC ACID LINEARITY TEST SET	Casco Standards	1989-07-20	86
K893140	DOCUMENT(TM) TRIGLYCERIDE LINEARITY TEST SET	Casco Standards	1989-06-23	59
K893141	DOCUMENT(TM) IRON MAGNESIUM LINEARITY TEST SET	Casco Standards	1989-06-23	59
K893142	DOCUMENT(TM) IRON, MAGNES, TRIGLY LINEAR TEST SET	Casco Standards	1989-06-23	59
K884197	DOCUMENT(TM) CHOLESTEROL CALIBRATOR SET	Casco Standards	1988-12-14	69
K883861	DOCUMENT(TM) PROTEIN/CHOLESTEROL LINEARITY TEST	Casco Standards	1988-10-13	30
K881773	DOCUMENT(TM) DIRECT ISE LINEARITY TEST SET	Casco Standards	1988-06-10	45
K870252	DOCUMENT(TM) MULTI-ANALYTE LINEARITY TEST SET	Casco Standards	1987-02-20	30
K861506	DOCUMENT ENZYME LINEARITY TEST SETS	Casco Standards	1986-06-13	51
K843947	DOUMENT TM LINEARITY TEST STANDARDS	Casco Standards	1984-10-17	8

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