Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Diagnostic Solutions, Inc. — Predicate Candidate Screening
26 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
63 daysmedian FDA review time
113 days90th percentile
26clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K934892 | RELIEF PLUS ONE REAGENT STRIP MODIFICATION | Diagnostic Solutions, Inc. | 1994-01-11 | 113 | 0 |
| K924398 | UNI-CHECK REAGENT STRIP | Diagnostic Solutions, Inc. | 1992-12-23 | 114 | 0 |
| K921825 | QUICK-CHECK II REAGENT STRIP | Diagnostic Solutions, Inc. | 1992-08-18 | 124 | 0 |
| K800689 | REAGENT FOR DETERM. GLUTAMIC-PYRUVIC- | Diagnostic Solutions, Inc. | 1980-05-30 | 65 | 0 |
| K800681 | REAGENTS FOR DETERM. CO2 IN HUMAN SERUM | Diagnostic Solutions, Inc. | 1980-05-30 | 65 | 0 |
| K800685 | REAGENT FOR DETERM. CREATININE IN H/SERU | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800672 | SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800675 | REAGENTS FOR DETERM. TOTAL BILIRUBIN | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800684 | REAGENT FOR DETERM. CREATINE PHOSPHOKINA | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800676 | REAGENTS FOR DETERM. SODIUM IN HUMAN SUM | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800690 | REAGENT FOR DETERM. INORGANIC/PHOSPHORUS | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800683 | REAGENT FOR DETERM. CHLORIDE IN HUMAN/SM | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800682 | REAGENTS FOR DETERM. CHOLESTEROL/SERUM | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800686 | REAGENT FOR DETERM. DIRECT BILIRUBIN | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800688 | REAGENT FOR DETERM. GLUTAMIC-OXALOACETIC | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800679 | REAGENTS FOR DETERM. ALKALINE PHOSPHATAS | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800677 | REAGENTS FOR DETERM. SERUM IRON IN HUMAN | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800691 | REAGENT FOR DETERM. LACTATE/DEHYDROGENAS | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800687 | REAGENT FOR DETERM. GLUCOSE IN H/SERUM | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800680 | REAGENTS FOR DETERM. CALCIUM IN HUMAN | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800678 | REAGENTS FOR DETERM. ALBUMIN IN HUMAN | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800692 | REAGENT FOR DETERM. POTASSIUM/IN HUMAN | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800673 | SMAC REPLACEMENT REAGENTS/OF BUN-SERUM | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800674 | SMAC REPLACEMENT/TOTAL PROTEIN HUMAN SER | Diagnostic Solutions, Inc. | 1980-05-28 | 63 | 0 |
| K800670 | SMAC REPLACEMENT REAGENTS, WETTING AGENT | Diagnostic Solutions, Inc. | 1980-04-16 | 21 | 0 |
| K800671 | SMAC REPLACEMENT REAGENTS-WASH SOLUTIONS | Diagnostic Solutions, Inc. | 1980-04-16 | 21 | 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