Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
American Scientific Products · Predicate Candidate Screening
28 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
31 daysmedian FDA review time
48 days90th percentile
28clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K864824 | INFECTIOUS TISSUE KIT | American Scientific Products | 1986-12-24 | 15 | 0 |
| K844042 | BLOOD DILUTION VIAL | American Scientific Products | 1984-10-23 | 6 | 0 |
| K831634 | GLUCOSE REAGENT B6360-11 | American Scientific Products | 1983-07-19 | 60 | 0 |
| K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 | American Scientific Products | 1983-07-07 | 48 | 0 |
| K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A | American Scientific Products | 1983-07-07 | 48 | 0 |
| K831627 | CREATININE REAGENTS B6360-10 | American Scientific Products | 1983-07-06 | 47 | 0 |
| K831624 | GLUCOSE REAGENT KITS-B6370-10A | American Scientific Products | 1983-07-06 | 47 | 0 |
| K831628 | CREATININE REAGENTS B6370-13 | American Scientific Products | 1983-07-06 | 47 | 0 |
| K831571 | ROTOR | American Scientific Products | 1983-06-30 | 45 | 0 |
| K831569 | REAGENT CUPS | American Scientific Products | 1983-06-30 | 45 | 0 |
| K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT | American Scientific Products | 1982-12-19 | 94 | 0 |
| K822988 | COAGULASE PLASMA-CITRATED & EDTA | American Scientific Products | 1982-11-05 | 24 | 0 |
| K822870 | STOOL-COLLECTION/PRESERVATION KIT | American Scientific Products | 1982-11-01 | 35 | 0 |
| K821660 | BIO-CHECK GRAM STAIN CONTROL | American Scientific Products | 1982-06-25 | 21 | 0 |
| K820683 | STAPHYLOCOCCUS LATEX AGGLUTINATION KIT | American Scientific Products | 1982-04-14 | 34 | 0 |
| K820532 | DISPO FIBRIN PIPET TIPS B4182-2 | American Scientific Products | 1982-04-08 | 37 | 0 |
| K820533 | B4182-1 | American Scientific Products | 1982-04-08 | 37 | 0 |
| K813359 | MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL | American Scientific Products | 1981-12-31 | 31 | 0 |
| K812187 | SMITH'S SYSTEMIC FUNGAL MEDIUM | American Scientific Products | 1981-08-31 | 28 | 0 |
| K812192 | LACTO-PHENOL ANILINE BLUE MOUNTING FLUID | American Scientific Products | 1981-08-31 | 28 | 0 |
| K812190 | COCCIDIOIDES IMMUNODIFFUSION SYSTEM | American Scientific Products | 1981-08-31 | 28 | 0 |
| K812188 | CRYPTOCOCCAL ANTIGEN LATEX AGGLUTI | American Scientific Products | 1981-08-31 | 28 | 0 |
| K812193 | KOH MOUNTING FLUID | American Scientific Products | 1981-08-31 | 28 | 0 |
| K812191 | VASPAR SEALENT | American Scientific Products | 1981-08-31 | 28 | 0 |
| K812194 | IMMUNODIFFUSION BAND INTENSIFYING FLUID | American Scientific Products | 1981-08-31 | 28 | 0 |
| K812185 | FUNGAL IMMUNODIFFUSION SYSTEM | American Scientific Products | 1981-08-25 | 22 | 0 |
| K812186 | CANDIDA IMMUNODIFFUSION SYSTEM | American Scientific Products | 1981-08-25 | 22 | 0 |
| K812189 | COCCIDIOIDES LATEX AGGLUTINATION | American Scientific Products | 1981-08-25 | 22 | 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