Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
Diamedix Corp. — Predicate Candidate Screening
68 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
67 daysmedian FDA review time
174 days90th percentile
68clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K093101 | MAGO 4S | Diamedix Corp. | 2011-01-21 | 477 | 0 |
| K021394 | DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM | Diamedix Corp. | 2002-07-09 | 68 | 0 |
| K013956 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN | Diamedix Corp. | 2002-01-08 | 39 | 0 |
| K013628 | DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM | Diamedix Corp. | 2001-12-21 | 46 | 0 |
| K012449 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM | Diamedix Corp. | 2001-10-26 | 86 | 0 |
| K012450 | DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM | Diamedix Corp. | 2001-10-26 | 86 | 0 |
| K012797 | DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM | Diamedix Corp. | 2001-09-28 | 38 | 0 |
| K012795 | DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM | Diamedix Corp. | 2001-09-28 | 38 | 1 |
| K012053 | DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM | Diamedix Corp. | 2001-08-20 | 49 | 0 |
| K002262 | DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM | Diamedix Corp. | 2000-11-28 | 126 | 1 |
| K001875 | DIAMEDIX IS-RUBELLA IGM CAPTURE TEST SYSTEM | Diamedix Corp. | 2000-08-21 | 62 | 0 |
| K001767 | DIAMEDIX IS-CMV IGM CAPTURE TEST SYSTEM | Diamedix Corp. | 2000-08-07 | 56 | 0 |
| K001707 | DIAMEDIX IS-TOXOPLASMA IGM CAPTURE TEST SYSTEM | Diamedix Corp. | 2000-07-07 | 32 | 0 |
| K994424 | DIAMEDIX IS-ANTI-DSDNA TEST SYSTEM | Diamedix Corp. | 2000-02-18 | 50 | 0 |
| K993294 | DIAMEDIX IS-ANA ELISA SCREEN TEST SYSTEM | Diamedix Corp. | 1999-10-25 | 24 | 0 |
| K981812 | EBV-VCA IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-03-04 | 286 | 0 |
| K981831 | IS EBV-EA-D IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 | 270 | 0 |
| K981829 | IS EBV-EBNA-1 IGG ELISA TEST SYSTEM | Diamedix Corp. | 1999-02-16 | 270 | 0 |
| K981729 | IS-RUBELLA IGG TEST SYSTEM | Diamedix Corp. | 1999-01-28 | 258 | 0 |
| K981306 | DIAMEDIX IS-HSV 1 & 2 IGG TEST SYSTEM | Diamedix Corp. | 1998-09-29 | 172 | 0 |
| K981867 | IS-VZU IGG TEST SYSTEM | Diamedix Corp. | 1998-09-28 | 123 | 0 |
| K981163 | DIAMEDIX IS-CMV IGG TEST SYSTEM | Diamedix Corp. | 1998-09-21 | 174 | 0 |
| K981498 | IS-TOXOPLASMA IGG TEST SYSTEM | Diamedix Corp. | 1998-08-21 | 116 | 0 |
| K980759 | DIAMEDIX IS-ENA-6 SCREEN TEST SYSTEM | Diamedix Corp. | 1998-04-23 | 55 | 1 |
| K974889 | DIAMEDIX IS-RF TEST SYSTEM | Diamedix Corp. | 1998-03-06 | 66 | 0 |
| K974694 | IS-DSDNA TEST SYSTEM | Diamedix Corp. | 1998-03-03 | 77 | 0 |
| K974552 | DIAMEDIX IS-MEASLES IGG TEST SYSTEM | Diamedix Corp. | 1998-01-28 | 55 | 1 |
| K973177 | MAGO AUTOMATED EIA PROCESSOR | Diamedix Corp. | 1997-10-09 | 45 | 0 |
| K970228 | IS-ANTI-JO-1 TEST SYSTEM | Diamedix Corp. | 1997-04-08 | 77 | 0 |
| K970220 | IS-ANTI-SM TEST SYSTEM | Diamedix Corp. | 1997-04-08 | 77 | 0 |
| K970218 | IS-ANTI-SSA TEST SYSTEM | Diamedix Corp. | 1997-04-08 | 77 | 0 |
| K970238 | IS-ANTI-SM/RNP (720-270) | Diamedix Corp. | 1997-04-08 | 77 | 0 |
| K970237 | IS-ANTI-SSB TEST SYSTEM (720-260) | Diamedix Corp. | 1997-04-08 | 77 | 0 |
| K970239 | IS-ANTI-SCL-70 TEST SYSTEM (720-280) | Diamedix Corp. | 1997-04-08 | 77 | 0 |
| K911679 | ANTI-JO-1 MICROASSAY | Diamedix Corp. | 1991-09-23 | 161 | 0 |
| K912020 | ANTI-DNA MICROASSAY | Diamedix Corp. | 1991-09-23 | 139 | 0 |
| K911330 | LYME IGM MICROASSAY | Diamedix Corp. | 1991-06-10 | 77 | 0 |
| K910899 | LYME DISEASE MICROASSAY | Diamedix Corp. | 1991-06-10 | 105 | 0 |
| K903961 | MEASLES IGG MICROASSAY | Diamedix Corp. | 1990-12-28 | 122 | 0 |
| K902915 | ANTI-SCI-70 MICROASSAY | Diamedix Corp. | 1990-09-06 | 65 | 0 |
| K900572 | LYME IGM MICROASSAY | Diamedix Corp. | 1990-05-02 | 84 | 0 |
| K901073 | ANTI-RNP MICROASSAY | Diamedix Corp. | 1990-03-19 | 11 | 0 |
| K900241 | ANTI-SSA MICROASSAY AND ANTI-SSB MICROASSAY | Diamedix Corp. | 1990-02-02 | 16 | 0 |
| K894894 | ANTI-SM MICROASSAY | Diamedix Corp. | 1989-08-24 | 23 | 0 |
| K890843 | LYME DISEASE MICROASSAY | Diamedix Corp. | 1989-07-25 | 154 | 0 |
| K890642 | VZV MICROASSAY | Diamedix Corp. | 1989-05-15 | 96 | 0 |
| K892127 | EZ COMPLEMENT C3 | Diamedix Corp. | 1989-04-14 | 18 | 0 |
| K892125 | EZ COMPLEMENT C2 | Diamedix Corp. | 1989-04-14 | 18 | 0 |
| K892129 | EZ COMPLEMENT C4 | Diamedix Corp. | 1989-04-14 | 18 | 0 |
| K891904 | EZ COMPLEMENT C1 | Diamedix Corp. | 1989-04-14 | 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