Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LIN — Predicate Candidate Screening
17 FDA 510(k) clearances under this product code; the 50 most recent screened below.
119 daysmedian FDA review time
324 days90th percentile
17clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K081164 | D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATIO | Diagnostic Hybrids, Inc. | 2008-06-13 | 50 | 0 |
| K983762 | NUCLISENS CMV PP67 | Organon Teknika Corp. | 1999-09-15 | 324 | 0 |
| K991650 | CMV BRITE TURBO KIT | Biotest Diagnostics Corp. | 1999-07-12 | 60 | 0 |
| K951821 | CYTOMEGALOVIRUS DIRECT IMMUNOFLUORESCENCE ASSAY | Light Diagnostics | 1996-06-07 | 414 | 0 |
| K951550 | CMV BRITE ANTIGENEMIA TEST KIT | Biotest Diagnostics Corp. | 1996-01-30 | 301 | 0 |
| K934798 | PATHODX CYTOMEGALOVIRUS | Diagnostic Products Corp. | 1994-03-25 | 169 | 0 |
| K921616 | CMV-VUE(TM) CMV ANTIGEN DETECTION KIT | Incstar Corp. | 1992-08-11 | 127 | 0 |
| K912592 | CMV-EA MAB TEST | Gull Laboratories, Inc. | 1991-12-04 | 177 | 0 |
| K905257 | OPUS CMV TEST SYSTEM | Pb Diagnostic Systems, Inc. | 1991-04-17 | 147 | 0 |
| K904036 | BARTELS CYTOMEGALOVIRUS IMMED. EARLY ANTIGEN | Baxter Healthcare Corp | 1990-10-16 | 41 | 0 |
| K894002 | CYTOMEGALOVIRUS FLUORESCENT MONOCLONAL ANTIBODY | Baxter Healthcare Corp | 1989-08-10 | 66 | 0 |
| K893468 | CMV IGG ANTIBODY TEST (INDIRECT FLUORESCENT TEST) | Immuno Concepts, Inc. | 1989-07-14 | 72 | 0 |
| K893467 | CMV IGG ANTIBODY TEST (INDIRECT ENZYME TEST) | Immuno Concepts, Inc. | 1989-07-14 | 72 | 0 |
| K860279 | CYTOMEGALOVIRUS DIRECT FLUORESCENT ANTIBODY KIT | Bartels Immunodiagnostic Supplies, Inc. | 1986-05-13 | 119 | 0 |
| K843138 | CMV TEST | Microbiological Research Corp. | 1985-01-29 | 173 | 0 |
| K822606 | CYTOMEGALOVIRUS ANTOBODY IGG | Immulok, Inc. | 1982-11-01 | 66 | 0 |
| K820895 | CYLOMEGALOVIRUS DIRECT FLUORESCENT ANTI | Bartels Immunodiagnostic Supplies, Inc. | 1982-05-03 | 34 | 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