Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Val Tech Diagnostics, Inc. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
45 daysmedian FDA review time
45 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883570 | HISTO-CHECK FUNGAL CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883567 | HISTO-CHECK LEGIONELLA CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883569 | HISTO-CHECK GRAM NEGATIVE SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883571 | HISTO-CHECK PARASITIC CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883568 | HISTO-CHECK ACID FAST SLIDES | Val Tech Diagnostics, Inc. | 1988-10-06 | 45 | 0 |
| K883684 | HERPES VIRUS CONTROL SLIDES | Val Tech Diagnostics, Inc. | 1988-09-28 | 30 | 0 |
| K883232 | HISTONE REACTIVE ANA | Val Tech Diagnostics, Inc. | 1988-09-07 | 37 | 0 |
| K883208 | HISTO-CHECK SLIDES | Val Tech Diagnostics, Inc. | 1988-08-25 | 27 | 0 |
| K871395 | DUAL SUBSTRATE ANA | Val Tech Diagnostics, Inc. | 1987-04-20 | 13 | 0 |
| K864668 | ANA TEST KIT | Val Tech Diagnostics, Inc. | 1987-03-12 | 100 | 0 |
| K870732 | RAT LIVER NUCLEI TEST SYSTEM | Val Tech Diagnostics, Inc. | 1987-03-10 | 13 | 0 |
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