Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Shield Diagnostics, Ltd. — Predicate Candidate Screening
27 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
68 daysmedian FDA review time
218 days90th percentile
27clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K000398 | SHIELD VON WILLEBRAND FACTOR ACTIVITY ELISA, MODEL FVWF 200 | Shield Diagnostics, Ltd. | 2000-04-17 | 70 | 0 |
| K982879 | SHIELD DIASTAT ANTI-B2 GLYCOPROTEIN 1 IGG (ELISA) ASSAY | Shield Diagnostics, Ltd. | 1998-10-15 | 62 | 1 |
| K980885 | SHIELD ACTIVATED FACTOR XII (ELISA) ASSAY | Shield Diagnostics, Ltd. | 1998-08-21 | 165 | 0 |
| K972981 | SHIELD HELICO-G2 ELISA KIT | Shield Diagnostics, Ltd. | 1998-03-17 | 218 | 0 |
| K962825 | SHIELD VON WILLEBRAND FACTOR ACTIVITY (ELISA) ASSAY | Shield Diagnostics, Ltd. | 1996-11-15 | 119 | 0 |
| K963525 | DIASTAT ANTI-GLOMERULAR BASEMENT MEMBRANE KIT | Shield Diagnostics, Ltd. | 1996-11-07 | 64 | 0 |
| K961515 | QUANTASE PHENYLALANINE ASSAY | Shield Diagnostics, Ltd. | 1996-06-12 | 63 | 1 |
| K955303 | DIASTAT ANTI-CARDIOLIPIN KIT | Shield Diagnostics, Ltd. | 1996-05-30 | 192 | 0 |
| K951487 | DIASTAT ANTI-THYROID PEROXIDASE KIT | Shield Diagnostics, Ltd. | 1995-06-30 | 91 | 0 |
| K952183 | DIASTAT ANTI-THYROGLOBULIN KIT | Shield Diagnostics, Ltd. | 1995-06-30 | 52 | 1 |
| K942813 | DIASTAT ANTI-PR3 (C-ANCA) KIT | Shield Diagnostics, Ltd. | 1995-03-06 | 265 | 0 |
| K943630 | DIASTAT ANTI-MPO (PANCA) KIT | Shield Diagnostics, Ltd. | 1995-03-06 | 223 | 0 |
| K944505 | DIASTAT ENA SINGLE WELL SCREEN KIT | Shield Diagnostics, Ltd. | 1994-11-21 | 68 | 1 |
| K932876 | DIASTAT ANTI-NUCLEAR ANTIBODY (ANA) KIT | Shield Diagnostics, Ltd. | 1993-11-15 | 154 | 1 |
| K932877 | DIASTAT ANTI-CENTROMERE KIT | Shield Diagnostics, Ltd. | 1993-10-15 | 123 | 0 |
| K923886 | DIASTAT TOTAL ANTI-CARDIOLIPIN KIT | Shield Diagnostics, Ltd. | 1992-09-25 | 52 | 0 |
| K921265 | DIASTAT ANTI-CARDIOLIPIN KIT | Shield Diagnostics, Ltd. | 1992-08-03 | 140 | 0 |
| K920616 | DIASTAT ANTI-HISTONE KIT | Shield Diagnostics, Ltd. | 1992-07-14 | 154 | 0 |
| K921183 | DIASTAT ANTI-MITOCHONDRIAL ANTIBODY KIT | Shield Diagnostics, Ltd. | 1992-06-19 | 102 | 1 |
| K912291 | DISTAT ANTI-SCL-70 KIT | Shield Diagnostics, Ltd. | 1991-07-30 | 68 | 1 |
| K912292 | DIASTAT ANTI-JO-1 KIT | Shield Diagnostics, Ltd. | 1991-07-30 | 68 | 0 |
| K905193 | DIASTAT ANTI-LA (SS-B) | Shield Diagnostics, Ltd. | 1990-12-13 | 24 | 0 |
| K905386 | DISTAT ANTI-DSDNA KIT | Shield Diagnostics, Ltd. | 1990-12-13 | 13 | 0 |
| K905194 | DIASTAT ANTI-RO (SS-A) | Shield Diagnostics, Ltd. | 1990-12-13 | 24 | 1 |
| K905191 | DIASTAT ANTI-SM | Shield Diagnostics, Ltd. | 1990-12-07 | 18 | 0 |
| K905192 | DIASTAT ANTI-SM/RNP | Shield Diagnostics, Ltd. | 1990-12-07 | 18 | 0 |
| K905190 | DIASTAT ENA PROFILE | Shield Diagnostics, Ltd. | 1990-12-07 | 18 | 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