Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LKT — Predicate Candidate Screening
23 FDA 510(k) clearances under this product code; the 50 most recent screened below.
91 daysmedian FDA review time
169 days90th percentile
23clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081928 | D3 DUET DFA RSV/RESPIRATORY VIRUS SCREENING KIT | Diagnostic Hybrids, Inc. | 2008-12-23 | 169 | 0 |
| K983336 | PATHODX RESPIRATORY VIRUS PANEL MODEL PKRP1 | Diagnostic Products Corp. | 1999-03-18 | 176 | 0 |
| K943317 | PATHODX RESPIRATORY SYNCYTIAL VIRUS (RSV) | Diagnostic Products Corp. | 1994-12-19 | 161 | 0 |
| K942173 | RSV ANTIGEN TEST | Neogenex | 1994-06-30 | 56 | 0 |
| K912842 | RSV-MAB TEST | Gull Laboratories, Inc. | 1991-12-09 | 166 | 0 |
| K912838 | BARTELS RESPIRATORY SYNCYTIAL VIRUS ENZYME IMMUNO | Baxter Diagnostics, Inc. | 1991-09-27 | 93 | 0 |
| K912371 | BIOMERIEUX RSV DIRECT IF KIT | Vitek Systems, Inc. | 1991-09-23 | 117 | 0 |
| K894623 | RESPIRATORY SYNCYTIAL VIRUS | Bion Ent., Ltd. | 1989-10-16 | 88 | 0 |
| K884192 | RSV IFA TEST KIT FOR DIRECT ANTIGEN DETECTION | Baxter Diagnostics, Inc. | 1988-11-22 | 47 | 0 |
| K882687 | ANTI-RESPIRATORY SYNCYTIAL VIRUS ANTIBODY TEST | Gull Laboratories, Inc. | 1988-08-30 | 61 | 0 |
| K873564 | GENETIC SYSTEMS RSV REAGENT CONTROL SLIDES | Genetic Systems Corp. | 1987-11-20 | 79 | 0 |
| K872701 | RESPIRATORY SYNCYTIAL VIRUS CF ANTIGEN & CONTROL | Sita, Inc. | 1987-09-18 | 73 | 0 |
| K872082 | RESPIRATORY SYNCYTIAL VIRUS CONTROL SLIDE | Medical Diagnostic Technologies, Inc. | 1987-07-31 | 63 | 0 |
| K870176 | GENETIC SYSTEMS RSV IMMUNOFLUORESCENCE TEST KIT | Genetic Systems Corp. | 1987-07-16 | 182 | 1 |
| K871230 | ANTIBODY ASSAY FOR DETEC. OF RESP. SYNCYTIAL VIRUS | Microscan Div. Baxter Healthcare Corp. | 1987-06-26 | 91 | 0 |
| K862321 | CELLMATICS RSV DETECTION SYSTEM | Difco Laboratories, Inc. | 1986-08-21 | 64 | 0 |
| K861379 | MONABRITE RESPIR SYNCYTIAL VIRUS(RSV) TEST KIT | Serono Diagnostics, Inc. | 1986-07-16 | 93 | 0 |
| K852472 | ABBOTT RSV EIA | Abbott Laboratories | 1985-09-17 | 98 | 0 |
| K852185 | RESPIRATORY SYNCYTIAL VIRUS DIRECT FLUORESCENT ANT | Bartels Immunodiagnostic Supplies, Inc. | 1985-08-19 | 91 | 0 |
| K844721 | INNOFLUOR PRIMIDONE | Innotron Diagnostics | 1985-01-08 | 35 | 0 |
| K842047 | ORTHO* RSV ANTIGEN ELISA TEST SYS | Ortho Diagnostic Systems, Inc. | 1984-10-05 | 137 | 0 |
| K841527 | ORTHO RESPIRATORY SYNCYTIAL VIRUS- | Ortho Diagnostic Systems, Inc. | 1984-08-12 | 122 | 0 |
| K831924 | ANTIBODY TO RESPIRATORY SYNCYTIAL VIRUS | Electro-Nucleonics Laboratories, Inc. | 1983-08-11 | 57 | 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