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

Allied Instrumentation Laboratory — Predicate Candidate Screening

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

36 daysmedian FDA review time

42 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K861901	MULTI-4 CO-OXIMETER CONTROL	Allied Instrumentation Laboratory	1986-06-17	32
K860365	PHENOBARBITAL TEST SYSTEM	Allied Instrumentation Laboratory	1986-03-17	42
K860286	IL TEST PHENYTOIN	Allied Instrumentation Laboratory	1986-03-05	36
K853858	IL TEST THEOPHYLLINE ASSAY	Allied Instrumentation Laboratory	1985-10-15	29
K852676	IL SYSTEM 1304 & 1306, PH/BLOOD GAS ANALYZERS	Allied Instrumentation Laboratory	1985-07-22	28
K851933	CLINICAL CHEMISTRY ANALYTICAL SYSTEM	Allied Instrumentation Laboratory	1985-06-10	39
K850748	I-L TEST, DIRECT BILIRUBIN SET	Allied Instrumentation Laboratory	1985-04-03	37

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