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

Fisher Diagnostics — Predicate Candidate Screening

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

94 daysmedian FDA review time

259 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K170652	ARCHITECT B.R.A.H.M.S PCT, ARCHITECT B.R.A.H.M.S PCT Calibra	Fisher Diagnostics	2017-06-01	90	0
K070640	ARCHITECT STAT TROPONIN-1; MYOGLOBIN	Fisher Diagnostics	2007-09-13	190	0
K052407	ARCHITECT ANTI-TPO IMMUNOASSAY, CALIBRATORS & CONTROLS	Fisher Diagnostics	2006-07-18	320	2
K052308	ARCHITECT ANTI-TG IMMUNOASSAY REAGENTS, CALIBRATORS, CONTROL	Fisher Diagnostics	2006-05-10	259	0
K042924	ARCHITECT STAT MYO IMMUNOASSAY	Fisher Diagnostics	2005-01-24	94	1
K041192	ARCHITECT STAT TROPONIN-I IMMUNOASSAY	Fisher Diagnostics	2004-08-12	98	3
K041596	ARCHITECT STAT CK-MB IMMUNOASSAY	Fisher Diagnostics	2004-07-21	37	0
K023362	FISHER DIAGNOSTICS THROMBOSCREEN 1000; PACIFIC HEMOSTASIS FI	Fisher Diagnostics	2002-12-09	63	0
K013397	PACIFIC HEMOSTASIS REFERENCE EMULSION	Fisher Diagnostics	2002-02-15	123	0
K010750	PACIFIC HEMOSTASIS INR CONTROL PLASMAS, MODEL CATALOG 100560	Fisher Diagnostics	2001-09-07	178	0
K850160	FISHER DIAGNOSTICS LATEST-CRP TEST KIT	Fisher Diagnostics	1985-04-19	94	0
K844346	FISHER DIAGNOSTICS PREGNACLONE SLIDE PREGNANCY TES	Fisher Diagnostics	1985-03-04	115	0
K844347	FISHER DIAG. PREGNACLONE TUBE PREGNANCY TEST KIT	Fisher Diagnostics	1985-01-23	75	0
K844047	FISHER DIAGNOSTICS SERA CHEM SMAC CALIBRATORS	Fisher Diagnostics	1984-11-09	23	0
K840921	THERACHEM TDC THERAPEUTIC DRUG CONTROL	Fisher Diagnostics	1984-04-05	34	0
K833514	TOXI CHEM SERUM ALCOHOL CONTROL	Fisher Diagnostics	1983-12-08	58	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