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

Portable Medical Laboratories, Inc. · Predicate Candidate Screening

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

51 daysmedian FDA review time
114 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K882101HEMOGLOBIN SCREENING DEVICEPortable Medical Laboratories, Inc.1988-07-01510
K874190CELL COUNTING GRID GRATICULEPortable Medical Laboratories, Inc.1988-01-05830
K871671URINOSCOPY FUNNELPortable Medical Laboratories, Inc.1987-05-20220
K864049MCARTHUR MICROSCOPE, STANDARD METAL VERSIONPortable Medical Laboratories, Inc.1986-10-29120
K854735MCARTHUR MICROSCOPE PLASTIC VERSION WITH ACC.Portable Medical Laboratories, Inc.1985-12-10150
K844476PORTABLE DIAGNOSTIC LABORATORYPortable Medical Laboratories, Inc.1985-03-131140
K844475SPECIMEN COLLECTION & TRANSPORT SYSTEMPortable Medical Laboratories, Inc.1985-02-06790
K844442RAPID DIAGNOSTIC KITPortable Medical Laboratories, Inc.1985-02-01770
K844473HAND-HELD SLIDE READERPortable Medical Laboratories, Inc.1985-01-04460

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