Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Meridian Diagnostics, Inc. · Predicate Candidate Screening
92 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
34 daysmedian FDA review time
194 days90th percentile
92clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K993914 | PREMIER TOXINS A&B, MODEL 616096 | Meridian Diagnostics, Inc. | 1999-12-10 | 23 | 2 |
| K990263 | IMMUNOCARD STAT! E. COLI O157:H7 | Meridian Diagnostics, Inc. | 1999-08-09 | 194 | 0 |
| K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST | Meridian Diagnostics, Inc. | 1999-06-25 | 203 | 0 |
| K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST | Meridian Diagnostics, Inc. | 1999-06-25 | 203 | 0 |
| K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA | Meridian Diagnostics, Inc. | 1998-12-17 | 93 | 1 |
| K982764 | PREMIER CRYPTOSPORIDIUM | Meridian Diagnostics, Inc. | 1998-12-03 | 119 | 0 |
| K982711 | PREMIER GIARDIA | Meridian Diagnostics, Inc. | 1998-11-25 | 113 | 0 |
| K980076 | PREMIER PLATINUM HPSA | Meridian Diagnostics, Inc. | 1998-05-12 | 124 | 0 |
| K980077 | PARA-PAK SPINCON | Meridian Diagnostics, Inc. | 1998-04-02 | 84 | 0 |
| K971585 | IMMUNOCARD STAT! ROTAVIRUS | Meridian Diagnostics, Inc. | 1997-08-20 | 111 | 0 |
| K961508 | IMMUNOCARD H. PYLORI | Meridian Diagnostics, Inc. | 1997-01-21 | 277 | 0 |
| K953839 | PREMIER HSV PLUS | Meridian Diagnostics, Inc. | 1996-05-23 | 281 | 0 |
| K955859 | IMMUNOCARD TOXIN A | Meridian Diagnostics, Inc. | 1996-04-18 | 113 | 0 |
| K953362 | PREMIER EHEC | Meridian Diagnostics, Inc. | 1995-11-14 | 120 | 2 |
| K950167 | PREMIER EHEC | Meridian Diagnostics, Inc. | 1995-04-14 | 87 | 0 |
| K945558 | PREMIER(TM) H. PYLORY | Meridian Diagnostics, Inc. | 1995-03-03 | 109 | 0 |
| K941560 | IMMUNOCARD H. PYLORI | Meridian Diagnostics, Inc. | 1994-12-08 | 251 | 0 |
| K943228 | MICROSPORIDIUM CONTROL SET | Meridian Diagnostics, Inc. | 1994-10-27 | 113 | 0 |
| K934550 | IMMUNOCARD MYCOPLASMA | Meridian Diagnostics, Inc. | 1994-09-20 | 363 | 0 |
| K933587 | IMMUNOCARD ROTAVIRUS | Meridian Diagnostics, Inc. | 1994-02-03 | 192 | 0 |
| K930778 | IMMUNOCARD MONO | Meridian Diagnostics, Inc. | 1993-12-27 | 314 | 0 |
| K931770 | PARA-PAK PLUS | Meridian Diagnostics, Inc. | 1993-06-15 | 67 | 0 |
| K926442 | PREMIER C. DIFFICILE, MODIFICATION | Meridian Diagnostics, Inc. | 1993-01-27 | 42 | 1 |
| K924979 | IMMUNOCARD(TM) C. DIFFICILE | Meridian Diagnostics, Inc. | 1993-01-26 | 117 | 0 |
| K924136 | PREMIER C. DIFFICILE TOXIN A CONTROLS | Meridian Diagnostics, Inc. | 1992-10-19 | 62 | 0 |
| K924062 | MERITEC C. DIFFICILE CONTROLS | Meridian Diagnostics, Inc. | 1992-10-19 | 68 | 0 |
| K923859 | PREMIER BLASTOMYCES | Meridian Diagnostics, Inc. | 1992-10-05 | 66 | 0 |
| K915700 | PERMIER HISTOPLASMA | Meridian Diagnostics, Inc. | 1992-07-30 | 220 | 0 |
| K915493 | PREMIER COCCIDIOIDES | Meridian Diagnostics, Inc. | 1992-07-10 | 214 | 0 |
| K912408 | MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA | Meridian Diagnostics, Inc. | 1991-07-24 | 54 | 0 |
| K905493 | MERISTAR-MP | Meridian Diagnostics, Inc. | 1991-01-30 | 54 | 0 |
| K904393 | PREMIER-CRYPTOCOCCAL ANTIGEN | Meridian Diagnostics, Inc. | 1991-01-25 | 122 | 0 |
| K904400 | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION | Meridian Diagnostics, Inc. | 1990-10-16 | 25 | 0 |
| K903456 | PREMIER-C. DIFFICILE TOXIN A | Meridian Diagnostics, Inc. | 1990-10-01 | 61 | 0 |
| K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM | Meridian Diagnostics, Inc. | 1990-03-12 | 153 | 0 |
| K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE | Meridian Diagnostics, Inc. | 1989-09-08 | 28 | 0 |
| K894246 | MERIVIEW TM TRICHOMONAS | Meridian Diagnostics, Inc. | 1989-08-15 | 55 | 0 |
| K892263 | MERIFLUOR(TM) -TRICHOMONAS | Meridian Diagnostics, Inc. | 1989-05-24 | 50 | 0 |
| K881608 | MERIFLUOR(TM) PNEUMOCYSTIS | Meridian Diagnostics, Inc. | 1988-08-04 | 114 | 0 |
| K880389 | MERITEC(TM)-CAMPY (JCL) | Meridian Diagnostics, Inc. | 1988-04-12 | 75 | 0 |
| K874078 | MERITEC(TM)-GC | Meridian Diagnostics, Inc. | 1987-12-09 | 64 | 0 |
| K873299 | MERIFLUOR(TM)-GIARDIA | Meridian Diagnostics, Inc. | 1987-09-16 | 29 | 0 |
| K870171 | (MERIFLUOR)TM-CRYPTOSPORIDIUM | Meridian Diagnostics, Inc. | 1987-03-16 | 61 | 0 |
| K860034 | PARA-PAK MACRO-CON | Meridian Diagnostics, Inc. | 1986-02-21 | 46 | 0 |
| K850269 | MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE | Meridian Diagnostics, Inc. | 1985-07-18 | 176 | 0 |
| K831599 | MERITEC-STREP GROUP A BETA-HEMOLYTIC | Meridian Diagnostics, Inc. | 1983-08-11 | 86 | 0 |
| K821100 | MERITECASTREP (TM) | Meridian Diagnostics, Inc. | 1982-05-13 | 23 | 0 |
| K820531 | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT | Meridian Diagnostics, Inc. | 1982-04-14 | 43 | 0 |
| K812817 | NEUTRAL DUFFERED FORMA-SCENT | Meridian Diagnostics, Inc. | 1981-11-10 | 34 | 0 |
| K811722 | PARA-PAK | Meridian Diagnostics, Inc. | 1981-07-15 | 27 | 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