Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Tech-Neal Scientific, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
42 daysmedian FDA review time
88 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K882256 | MAGNESIUM REAGENT SET | Tech-Neal Scientific, Inc. | 1988-08-08 | 69 | 0 |
| K882459 | DIAZO, COLORIMETRIC BILIRUBIN | Tech-Neal Scientific, Inc. | 1988-08-02 | 48 | 0 |
| K881239 | GAMMA GLUTAMYL TRANSFERASE REAGENT SET | Tech-Neal Scientific, Inc. | 1988-05-31 | 70 | 0 |
| K881241 | TOTAL BILIRUBIN REAGENT | Tech-Neal Scientific, Inc. | 1988-05-27 | 66 | 0 |
| K881237 | CREATINE KINASE (CK) REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-28 | 37 | 0 |
| K881240 | CHLORIDE REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-28 | 37 | 0 |
| K880237 | CHOLESTEROL | Tech-Neal Scientific, Inc. | 1988-04-28 | 99 | 1 |
| K880277 | URIC ACID REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-18 | 88 | 0 |
| K880844 | ALBUMIN REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | 39 | 0 |
| K880843 | CREATININE REAGENT SET (KINETIC) | Tech-Neal Scientific, Inc. | 1988-04-05 | 39 | 0 |
| K880842 | LDH-L REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | 39 | 0 |
| K880845 | CALCIUM REAGENT SET | Tech-Neal Scientific, Inc. | 1988-04-05 | 39 | 0 |
| K880676 | INORGANIC PHOSPHORUS REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-24 | 34 | 0 |
| K880677 | TOTAL PROTEIN REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-24 | 34 | 0 |
| K880236 | GLUCOSE HEXOKINASE | Tech-Neal Scientific, Inc. | 1988-03-15 | 55 | 0 |
| K880238 | TRIGLYCERIDE | Tech-Neal Scientific, Inc. | 1988-03-15 | 55 | 0 |
| K880307 | ALKALINE PHOSPHATASE REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-15 | 50 | 0 |
| K880276 | AST (SGOT) REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-03 | 42 | 0 |
| K880275 | ALT (SGPT) REAGENT SET | Tech-Neal Scientific, Inc. | 1988-03-01 | 40 | 0 |
| K880078 | UREA NITROGEN (BUN) | Tech-Neal Scientific, Inc. | 1988-02-11 | 31 | 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