Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Consolidated Technologies, Inc. — Predicate Candidate Screening
20 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
37 daysmedian FDA review time
155 days90th percentile
20clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000116 | QUALITROL URINALYSIS WITH MICROSCOPICS CONTROL, LEVELS 1,2 A | Consolidated Technologies, Inc. | 2000-02-15 | 32 | 0 |
| K992576 | URINE CHEMISTRY CONTROL, LEVEL 1 | Consolidated Technologies, Inc. | 1999-09-03 | 32 | 0 |
| K992578 | URINE CHEMISTRY CONTROL, LEVEL 2 | Consolidated Technologies, Inc. | 1999-09-03 | 32 | 0 |
| K992151 | REFERENCE MATERIAL FOR DELTA-9-THC-COOH IN HUMAN URINE | Consolidated Technologies, Inc. | 1999-07-14 | 20 | 0 |
| K981339 | QUICKCHECK LYOPHILIZED CHEMISTRY CONTROL CONFORMANCE CHEMIST | Consolidated Technologies, Inc. | 1998-04-21 | 8 | 0 |
| K974699 | REFERENCE MATERIAL FOR AMPHETAMINE/METHAMPHETAMINE IN HUMAN | Consolidated Technologies, Inc. | 1998-01-22 | 37 | 0 |
| K973469 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 AND 2, CONFOR | Consolidated Technologies, Inc. | 1997-09-25 | 21 | 0 |
| K972146 | QUALITROL UNASSAYED H. PYLORI CONTROL SET POSITIVE AND NEGAT | Consolidated Technologies, Inc. | 1997-07-08 | 29 | 0 |
| K972080 | QUALITROL DHP IMMUNOASSAY CONTROL LEVELS 1,2 AND 3, CONFORMA | Consolidated Technologies, Inc. | 1997-06-18 | 15 | 0 |
| K961815 | QUALITROL ANA CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-27 | 140 | 0 |
| K961545 | QUALITROL RF CONTROLS | Consolidated Technologies, Inc. | 1996-09-24 | 155 | 0 |
| K961544 | QUALITROL IGAME CONTROLS, LEVELS 1 AND 2 | Consolidated Technologies, Inc. | 1996-09-24 | 155 | 0 |
| K961550 | QUALITROL MONO CONTROL SERUM SET | Consolidated Technologies, Inc. | 1996-09-24 | 155 | 0 |
| K963346 | STABILYPH UNASSAYED LIGAND ASSASY CONTROL, LEVELS 1, 2 AND 3 | Consolidated Technologies, Inc. | 1996-09-09 | 14 | 0 |
| K961829 | QUALITROL CRP CONTROL SET | Consolidated Technologies, Inc. | 1996-08-19 | 98 | 0 |
| K961912 | QUALITROL, (ALFA FETOPROTEIN) AFP CONTROL SET | Consolidated Technologies, Inc. | 1996-08-15 | 90 | 0 |
| K961998 | QUALITROL SYPHSERO CONTROL SET | Consolidated Technologies, Inc. | 1996-08-08 | 78 | 0 |
| K961293 | QUIKCHECK UNASSAYED CHEMISTRY CONTROL LEVELS 1 & 2 | Consolidated Technologies, Inc. | 1996-05-02 | 28 | 0 |
| K933557 | REFERENCE MATERIAL FOR PHENCYCLIDINE IN HUMAN URINE | Consolidated Technologies, Inc. | 1993-09-10 | 51 | 0 |
| K905457 | CLINICAL CHEMISTRY QUALITY CONTROL MATERIAL | Consolidated Technologies, Inc. | 1991-04-16 | 132 | 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