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

Hamilton Co. — Predicate Candidate Screening

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

48 daysmedian FDA review time

104 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K961896	MICROLAB 4000, MICROLAB 4200	Hamilton Co.	1996-08-16	92	0
K943493	DISCRETE PHOTOMETRIC CHEMISTRY ANALYZER	Hamilton Co.	1995-01-30	195	1
K892369	MULTI-PROBE HEAD PLUS	Hamilton Co.	1989-06-02	57	0
K873893	LUMICON	Hamilton Co.	1988-01-05	104	0
K871945	MICROLAB AT	Hamilton Co.	1987-05-29	10	1
K832202	PB 600 REPEATING DISPENSER	Hamilton Co.	1983-08-24	48	0
K832205	PRECISION LIQUID DISPENSER	Hamilton Co.	1983-08-24	48	0
K832204	MICROLAB P	Hamilton Co.	1983-08-24	48	0
K832201	CHROM-PREP	Hamilton Co.	1983-08-16	40	0
K832200	PRP-1 REVERSED PHASE COLUMNS FOR HPLC	Hamilton Co.	1983-08-16	40	0
K832199	HC40/HC75 CATION EXCHANGE RESIN	Hamilton Co.	1983-08-16	40	0
K832197	PRP-1 REVERSED PHASE RESIN	Hamilton Co.	1983-08-12	36	0
K832198	HC40/HC75 PREPACKED COLUMS	Hamilton Co.	1983-08-12	36	0
K832203	MULTI-TITER DISPENSER	Hamilton Co.	1983-08-08	32	0
K822688	DIGITAL DILUTER/DISPENSERS	Hamilton Co.	1982-11-05	63	0
K801913	MICROLAB M-MICROPROCESSOR DILUTER/DISP	Hamilton Co.	1980-09-26	46	0

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