Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Jas Diagnostics, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
59 daysmedian FDA review time
257 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K130915 | XL-200 CLINICAL CHEMISTRY ANALYZER, JAS GLUCOSE REAGENT, ISE | Jas Diagnostics, Inc. | 2014-05-15 | 408 | 0 |
| K080623 | CHOLESTEROL OXIDASE JASE, AND GLYCEROL INASE TRIGLYCERIDES, | Jas Diagnostics, Inc. | 2008-11-17 | 257 | 0 |
| K080618 | DIRECT HBA1C, FRUCTOSAMINE, GLUCOSE OXIDASE LIQUID | Jas Diagnostics, Inc. | 2008-05-23 | 79 | 0 |
| K022519 | LDL CHOLESTEROL (AUTOMATED) | Jas Diagnostics, Inc. | 2002-09-30 | 62 | 1 |
| K021671 | JAS HDL CHOLESTEROL (AUTOMATED) REAGENT | Jas Diagnostics, Inc. | 2002-07-19 | 59 | 0 |
| K020454 | CHEMISTRY CALIBRATOR | Jas Diagnostics, Inc. | 2002-04-08 | 56 | 0 |
| K020282 | JAS AMYLASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2002-02-28 | 31 | 0 |
| K013912 | CREATINE KINASE (CK-NAC) | Jas Diagnostics, Inc. | 2002-01-18 | 52 | 0 |
| K013698 | AST (SGOT) | Jas Diagnostics, Inc. | 2001-12-21 | 44 | 0 |
| K012332 | JAS CARBON DIOXIDE LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-09-06 | 45 | 0 |
| K012038 | JAS URIC ACID LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-08-21 | 53 | 0 |
| K011900 | GLUCOSE (HEXOKINASE) | Jas Diagnostics, Inc. | 2001-07-31 | 43 | 2 |
| K011599 | ALKALINE PHOSPHATASE LIQUID REAGENT | Jas Diagnostics, Inc. | 2001-07-20 | 57 | 0 |
| K011441 | JAS CALCIUM (ARSENAZO) REAGENT | Jas Diagnostics, Inc. | 2001-07-09 | 60 | 0 |
| K003835 | JAS MAGNESIUM REAGENT | Jas Diagnostics, Inc. | 2001-03-23 | 101 | 0 |
| K003912 | PHOSPHORUS REAGENT | Jas Diagnostics, Inc. | 2001-02-21 | 64 | 0 |
| K003829 | TOTAL BILIRUBIN | Jas Diagnostics, Inc. | 2001-02-12 | 63 | 0 |
| K003693 | DIRECT BILIRUBIN | Jas Diagnostics, Inc. | 2001-01-29 | 60 | 0 |
| K003247 | CREATININE | Jas Diagnostics, Inc. | 2000-12-14 | 58 | 0 |
| K003327 | ALBUMIN | Jas Diagnostics, Inc. | 2000-12-05 | 42 | 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