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

Reagent Laboratory, Inc. — Predicate Candidate Screening

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

41 daysmedian FDA review time
71 days90th percentile
19clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K863502SOLUTION B- NA 50MEQ/L, K 40 MEQ/LReagent Laboratory, Inc.1986-10-21420
K863503HEMOLYSEReagent Laboratory, Inc.1986-10-03240
K863550POTASSIUM HYDROXIDE 10% W/VReagent Laboratory, Inc.1986-10-02200
K860143URINE DILUENT-FOR USE WITH ION SELECTIVE ELECTRODEReagent Laboratory, Inc.1986-02-10260
K842982FORMALIN BUFFEREDReagent Laboratory, Inc.1984-10-01630
K842785STAIN, METHYLENE BLUE-EOSINReagent Laboratory, Inc.1984-09-11710
K843050GRAM STAINReagent Laboratory, Inc.1984-09-11390
K841847LITHIUM REAGENTReagent Laboratory, Inc.1984-08-171210
K843051WRIGHTS STAIN SOLUTIONReagent Laboratory, Inc.1984-08-0300
K841800LYSING & HEMOGLOBIN REAGENTReagent Laboratory, Inc.1984-05-31430
K841799CYANOMETHEMOGLOBIN REAGENTReagent Laboratory, Inc.1984-05-31430
K841423SCOTTS TAP WATER SUBSTITUTE 7Reagent Laboratory, Inc.1984-05-22470
K841183SODIUM CHLORIDE SOLUTION BLOOD CELLReagent Laboratory, Inc.1984-05-21620
K841418SODIUM ELECTRODE RINSE SOLUTION 2Reagent Laboratory, Inc.1984-05-16410
K841417POTASSIUM CHLORIDE SOLUTION -2 MOLARReagent Laboratory, Inc.1984-05-16410
K841419SODIUM & POTASSIUM STANDARD SOLUTReagent Laboratory, Inc.1984-05-11360
K841420SODIUM & POTASSIUM STANDARD SOL 80Reagent Laboratory, Inc.1984-05-11360
K841421DAILY WASH SOLUTION 5Reagent Laboratory, Inc.1984-05-11360
K841422VOLUME TEST DYE 6Reagent Laboratory, Inc.1984-05-11360

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