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

Texas Intl. Laboratories, Inc. — Predicate Candidate Screening

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

104 daysmedian FDA review time
231 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K953643HEMATIL 18 (H-18)Texas Intl. Laboratories, Inc.1996-03-222310
K904031CHEMA CHOL CHOLESTEROL SYSTEMTexas Intl. Laboratories, Inc.1991-03-111920
K900684RDW AND MPV INDICES ON HEMAT 12Texas Intl. Laboratories, Inc.1990-04-16630
K900685CLOT 2 SEMIAUTOMATIC COAGULATION ANALYZERTexas Intl. Laboratories, Inc.1990-04-16630
K884006HEMAT 12Texas Intl. Laboratories, Inc.1988-12-05750
K883177H 10 OR HEMATIL 10 BLOOD CELL & PLATELET COUNTERTexas Intl. Laboratories, Inc.1988-11-301260
K853722PLT-4 PLATELET ANALYZERTexas Intl. Laboratories, Inc.1986-01-171340
K832886FLAME PHOTOMETER T281-T282-T283Texas Intl. Laboratories, Inc.1983-12-081040
K832890HEMACOMP 7 OR HEMATIL 7Texas Intl. Laboratories, Inc.1983-10-19540
K831649THERMOMIXER S213-PHOTOANALYZER S263Texas Intl. Laboratories, Inc.1983-08-24930

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