Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
CKD · Predicate Candidate Screening
11 FDA 510(k) clearances under this product code; the 50 most recent screened below.
52 daysmedian FDA review time
108 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K991834 | CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772 | Cholestech Corp. | 1999-09-09 | 104 | 1 |
| K941192 | ORTHO ALT MICROWELL TEST SYSTEM | Ortho Diagnostic Systems, Inc. | 1995-05-16 | 428 | 0 |
| K896237 | COBAS READY ALT REAGENT | Roche Diagnostic Systems, Inc. | 1990-02-16 | 108 | 0 |
| K884784 | VIRGO(R) MICROWELL ALT ASSAY | Electro-Nucleonics, Inc. | 1988-12-29 | 44 | 0 |
| K883387 | ALANINE AMINO TRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-10-13 | 64 | 0 |
| K864082 | REFLOTRON(R) ALT (GPT) | Boehringer Mannheim Corp. | 1986-12-04 | 45 | 1 |
| K860485 | SGPT (ALT) REAGENT SET (COLORIMETRIC) | Sterling Diagnostics, Inc. | 1986-04-03 | 52 | 0 |
| K844283 | SGPT REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-27 | 22 | 0 |
| K841059 | SGPT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 | 50 | 0 |
| K821207 | SGPT REAGENT SET | Omega Medical Electronics | 1982-07-14 | 78 | 0 |
| K820491 | SGPT REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 | 16 | 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