Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Nobel Scientific Industries, Inc. · Predicate Candidate Screening
23 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
28 daysmedian FDA review time
65 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K854717 | NSI ASTRA TM TOTAL PROTEIN REAGENT KIT, NSI #7928 | Nobel Scientific Industries, Inc. | 1986-01-14 | 53 | 0 |
| K854716 | NSI ASTRA TM CALCIUM REAGENT KIT NSI ITEM # 7909 | Nobel Scientific Industries, Inc. | 1986-01-07 | 46 | 0 |
| K854718 | NSI ASTRA TM ALBUMIN REAGENT KIT NSI ITEM # 7926 | Nobel Scientific Industries, Inc. | 1985-12-19 | 27 | 0 |
| K850944 | NSI LYSING-D REAGENT -4000 ML | Nobel Scientific Industries, Inc. | 1985-03-29 | 22 | 0 |
| K844782 | NSI ELT-D DILUTING FLUID 4000ML | Nobel Scientific Industries, Inc. | 1985-03-05 | 85 | 0 |
| K823283 | FLUSHING SOLUTION | Nobel Scientific Industries, Inc. | 1982-12-03 | 29 | 0 |
| K812866 | ASTRA REAGENT CONCENTRATE SYSTEM | Nobel Scientific Industries, Inc. | 1981-12-17 | 65 | 0 |
| K810550 | SILVER ANODE | Nobel Scientific Industries, Inc. | 1981-04-08 | 37 | 0 |
| K810549 | THERMAL PRINTER PAPER | Nobel Scientific Industries, Inc. | 1981-04-08 | 37 | 0 |
| K802518 | BUN REAGENT ASTRA 4 & 8 ANALYZERS | Nobel Scientific Industries, Inc. | 1980-11-12 | 28 | 0 |
| K801346 | NSI REAGENT SYSTEM FOR ORTHO ELT-8 HEMA | Nobel Scientific Industries, Inc. | 1980-08-12 | 64 | 0 |
| K800587 | NSI WASH SOLUTION CONCENTRATE | Nobel Scientific Industries, Inc. | 1980-08-08 | 144 | 0 |
| K801506 | CERTIFIED BLOOD BANK SALINE | Nobel Scientific Industries, Inc. | 1980-07-28 | 28 | 0 |
| K800586 | NSI CARBON DIOXIDE REAGENT KIT | Nobel Scientific Industries, Inc. | 1980-04-04 | 18 | 0 |
| K800588 | NSI CALIBRATOR SET | Nobel Scientific Industries, Inc. | 1980-04-04 | 18 | 0 |
| K800589 | GLUCOSE OXIDASE REAGENT | Nobel Scientific Industries, Inc. | 1980-04-04 | 18 | 0 |
| K800590 | BUN KIT | Nobel Scientific Industries, Inc. | 1980-04-04 | 18 | 0 |
| K800585 | NSI CHLORIDE REAGENT KIT | Nobel Scientific Industries, Inc. | 1980-04-02 | 16 | 0 |
| K800583 | NSI CREATININE KIT | Nobel Scientific Industries, Inc. | 1980-04-02 | 16 | 0 |
| K800584 | NSI SODIUM/POTASSIUM KIT | Nobel Scientific Industries, Inc. | 1980-04-02 | 16 | 0 |
| K781396 | CREATININE REAGENT SET | Nobel Scientific Industries, Inc. | 1978-09-14 | 35 | 0 |
| K781275 | CHLORIDE/CARBON DIOXIDE REAGENT SET | Nobel Scientific Industries, Inc. | 1978-08-31 | 38 | 0 |
| K761181 | GLUCOSE OXIDASE REAGENT SYSTEM | Nobel Scientific Industries, Inc. | 1976-12-13 | 11 | 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