Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Biophor Diagnostics, Inc. · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
324 daysmedian FDA review time
447 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142293 | Rapidfret Oral Fluid Assay for Methamphetamine, Rapidfret Or | Biophor Diagnostics, Inc. | 2015-09-18 | 396 | 0 |
| K142129 | RAPIDFRET ORAL FLUID ASSAY FOR COCAINE, RAPIDFRET ORAL FLUID | Biophor Diagnostics, Inc. | 2015-07-24 | 354 | 0 |
| K141748 | RAPIDFRET ORAL FLUID ASSAY FOR AMPHETAMINE, RAPIDFRET ORAL F | Biophor Diagnostics, Inc. | 2015-05-20 | 324 | 0 |
| K133047 | RAPIDFRET ORAL FLUID ASSAY FOR MDMA, RAPIDFRET ORAL FLUID CA | Biophor Diagnostics, Inc. | 2014-12-18 | 447 | 0 |
| K133642 | RAPIDFRET ORAL FLUID ASSAY FOR OPIATES; RAPIDFRET ORAL FLUID | Biophor Diagnostics, Inc. | 2014-01-24 | 58 | 0 |
| K132096 | RAPIDFRET ORAL FLUID ASSAY FOR THC, THC CALIBRATOR SET, THC | Biophor Diagnostics, Inc. | 2013-10-18 | 102 | 0 |
| K122703 | RAPIDFRET ORAL FLUID ASSAY FOR PCP, PCP CALIBRATOR SET, PCP | Biophor Diagnostics, Inc. | 2013-04-25 | 233 | 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