Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
DBL — Predicate Candidate Screening
24 FDA 510(k) clearances under this product code; the 50 most recent screened below.
98 daysmedian FDA review time
364 days90th percentile
24clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K180202 | Histofluor Rodent LKS Fluorescent Antibody Test System, Imag | Immuno Concepts, N.A. , Ltd. | 2018-10-19 | 268 | 0 |
| K980312 | NOVA LITE ENDOMYSIAL | Inova Diagnostics, Inc. | 1998-04-02 | 65 | 0 |
| K974169 | WIELISA ANTI-GBM TEST SYSTEM | Wieslab AB | 1998-02-17 | 104 | 0 |
| K971464 | IMMUNOSCAN ANTI-GBM QUANTITATIVE KIT | Euro-Diagnostica AB | 1997-10-29 | 190 | 0 |
| K971658 | MOUSE LIVER KIDNEY STOMACH DIAGNOSTIC TEST KIT | Jay H. Geller | 1997-05-23 | 39 | 0 |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Shield Diagnostics, Ltd. | 1996-11-07 | 64 | 0 |
| K955431 | RIT LIVER, KIDNEY, STOMACH IFA KIT | The Binding Site, Ltd. | 1996-04-23 | 147 | 0 |
| K953495 | EIA KIT FOR THE DETECTION OF GBM ANTIBODIES | Scimedx Corp. | 1996-04-10 | 259 | 0 |
| K944191 | ANTI-NUCLEAR ANTIBODY(ANA) TEST KIT W/MOUSE LIVER | Light Diagnostics | 1995-03-06 | 189 | 0 |
| K944192 | ANTI-NUCLEAR ANTIBODY (ANA) TEST KIT W/RAT LIVER | Light Diagnostics | 1995-03-06 | 189 | 0 |
| K913360 | ANTI-RETICULIN ANTIBODY (ARA) TEST | Immco Diagnostics, Inc. | 1994-09-26 | 1155 | 0 |
| K912551 | ANTI-ENDOMYSIAL ANTIBODY TEST | Immco Diagnostics, Inc. | 1993-06-09 | 729 | 0 |
| K904181 | ANTI-GBM ANTIBODIES QUANTITATIVE KIT | Biochemical Diagnostic, Inc. | 1991-09-10 | 364 | 0 |
| K902237 | MEDICA IIF ANTI-SKIN ANTIBODY TEST KIT | Medica Corp. | 1990-07-09 | 52 | 0 |
| K891098 | ANTI-SKIN ANTIBODY TEST(MONKEY ESOPHAGUS SECTIONS) | Immco Diagnostics, Inc. | 1989-03-22 | 20 | 0 |
| K891099 | ANTI-SKIN ANTIBODY TEST(MONKEY/GUIN PIG ESOPH SEC) | Immco Diagnostics, Inc. | 1989-03-22 | 20 | 0 |
| K883915 | AUTOANTIBODY TEST SYSTEM (MOUSE KIDNEY/STOMACH) | Immco Diagnostics, Inc. | 1988-10-19 | 33 | 0 |
| K871194 | I-125 ANTI-MICROSOMAL ANTIBODY IRMA TEST KIT | Cronus | 1987-04-20 | 27 | 0 |
| K821576 | ANTINUCLEAR ANTIBODY SCREEN FLOURESC | Immuno-Products Industries | 1982-06-10 | 13 | 0 |
| K820088 | AFT SYSTEM PROFICIENCY TESTING PROGRAM | Calbiochem-Behring Corp. | 1982-01-26 | 13 | 0 |
| K811261 | ANTI-SKIN ANTIBODY TEST SYSTEM | Zeus Scientific, Inc. | 1981-08-12 | 98 | 0 |
| K801960 | ANTI-DS/N-DNA TEST KIT | Immuno-Diagnostic Products, Inc. | 1980-10-10 | 52 | 0 |
| K792610 | KALLESTAD FLORESCENT ANA/AMA/ASMA TEST | Kallestad Laboratories, Inc. | 1980-02-22 | 66 | 1 |
| K791996 | MULTIPLE AUTO ANTIBODY TEST | Meda Stat Diagnostics, Inc. | 1980-01-16 | 105 | 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