Atlas FDA

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

In Vitro Diagnostics, Inc. — Predicate Candidate Screening

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

65 daysmedian FDA review time
79 days90th percentile
15clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K896867THYROID STIMULATING HORMONE-EIA-XTIn Vitro Diagnostics, Inc.1990-02-23790
K896866LUTEINIZING HORMONE-EIA-XTIn Vitro Diagnostics, Inc.1990-02-13690
K896863DIGOXIN-EIA-XTIn Vitro Diagnostics, Inc.1990-02-13690
K896865VITRO T4-EIA-XTIn Vitro Diagnostics, Inc.1990-01-30550
K896925T UPTAKE ENZYME IMMUNOASSAY CRIMPED TUBE KITIn Vitro Diagnostics, Inc.1990-01-18370
K896864FOLLICLE STIMULATING HORMONE-EIA-XTIn Vitro Diagnostics, Inc.1990-01-11360
K873832REAGENTS FOR USE ON CONTRAVES DC300, DC500, AL801In Vitro Diagnostics, Inc.1987-11-23630
K871185LITHIUM INTERNAL STANDARD 1 MEQ/L #60085In Vitro Diagnostics, Inc.1987-05-28650
K871182FLAME PHOTOMETER STANDARD #60081 120 NA/2KIn Vitro Diagnostics, Inc.1987-05-28650
K871187LITHIUM INTERNAL STANDARD 3000 MEQ/L #60084In Vitro Diagnostics, Inc.1987-05-28650
K871183FLAME PHOTOMETER STANDARD #60082 140 NA/5KIn Vitro Diagnostics, Inc.1987-05-28650
K871188LITHIUM INTERNAL STANDARD 1500 MEQ/L #60086In Vitro Diagnostics, Inc.1987-05-28650
K871186CESIUM DILUENT 1.5 MMOL CS/L #60087In Vitro Diagnostics, Inc.1987-05-28650
K871184FLAME PHOTOMETER STANDARD #60083 160 NA/8KIn Vitro Diagnostics, Inc.1987-05-28650
K85330421 HEMATOLOGY REAGENTSIn Vitro Diagnostics, Inc.1985-11-12990

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