Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Crestat Diagnostics, Inc. — Predicate Candidate Screening
29 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
195 daysmedian FDA review time
276 days90th percentile
29clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980883 | N-ASSAY GLU-UL | Crestat Diagnostics, Inc. | 1998-09-03 | 178 | 0 |
| K981276 | N-ASSAY L D-BIL | Crestat Diagnostics, Inc. | 1998-05-01 | 23 | 0 |
| K981289 | N-ASSAY L T-BIL | Crestat Diagnostics, Inc. | 1998-04-27 | 19 | 0 |
| K980900 | N-ASSAY CPK-L | Crestat Diagnostics, Inc. | 1998-03-26 | 16 | 0 |
| K980902 | N-ASSAY L AST/GOT | Crestat Diagnostics, Inc. | 1998-03-26 | 16 | 0 |
| K972257 | N-ASSAY TIA ANTITHROMBIN III TEST KIT | Crestat Diagnostics, Inc. | 1997-10-20 | 125 | 0 |
| K971985 | N-ASSAY TIA PLASMINOGEN TEST KIT | Crestat Diagnostics, Inc. | 1997-10-20 | 144 | 0 |
| K964294 | N-ASSAY TIA APO A1/B MULTI CALIBRATOR | Crestat Diagnostics, Inc. | 1997-08-01 | 276 | 0 |
| K964296 | N-ASSAY TIA APO B TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 | 276 | 0 |
| K964292 | N-ASSAY TIA APO A1 TEST KIT | Crestat Diagnostics, Inc. | 1997-08-01 | 276 | 0 |
| K964299 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | 258 | 0 |
| K964301 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | 258 | 0 |
| K964298 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | 258 | 0 |
| K964297 | N-ASSAY TIA C4 TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 | 258 | 0 |
| K964300 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1997-07-14 | 258 | 0 |
| K965100 | N-ASSAY TIA ALPHA-1-ANTITRYPSIN TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 | 206 | 1 |
| K965024 | N-ASSAY TIA C1-INACTIVATOR TEST KIT | Crestat Diagnostics, Inc. | 1997-07-14 | 209 | 0 |
| K965110 | N-ASSAY TIA MULTI CRP CALIBRATOR SET | Crestat Diagnostics, Inc. | 1997-07-03 | 195 | 0 |
| K964295 | N-ASSAY TIA TRANSFERRIN TEST KIT | Crestat Diagnostics, Inc. | 1997-06-16 | 230 | 0 |
| K965113 | N-ASSAY TIA FIBRINOGEN TEST KIT | Crestat Diagnostics, Inc. | 1997-04-16 | 117 | 0 |
| K933971 | N-ASSAY TIA IGA | Crestat Diagnostics, Inc. | 1994-03-22 | 221 | 0 |
| K933972 | N-ASSAY TIA IGG | Crestat Diagnostics, Inc. | 1994-03-22 | 221 | 0 |
| K933970 | N-ASSAY TIA IGM | Crestat Diagnostics, Inc. | 1994-03-22 | 221 | 0 |
| K933973 | N-ASSAY TIA MULTI V-NL | Crestat Diagnostics, Inc. | 1994-01-28 | 168 | 0 |
| K934146 | N-ASSAY TIA MICROALBUMIN | Crestat Diagnostics, Inc. | 1994-01-11 | 140 | 0 |
| K934143 | N-ASSAY TIA MICROALBUMIN CALIBRATOR SET | Crestat Diagnostics, Inc. | 1993-11-05 | 73 | 0 |
| K914155 | TIA CRP TEST KIT | Crestat Diagnostics, Inc. | 1992-01-15 | 121 | 0 |
| K912148 | CHOLINESTERASE TEST KIT | Crestat Diagnostics, Inc. | 1991-08-12 | 89 | 0 |
| K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT | Crestat Diagnostics, Inc. | 1990-09-07 | 93 | 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