Company ยท US
Meridian Diagnostics, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1980 to 1999. Name variants (Inc, Corp, punctuation) are merged.
92510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LLH | Reagents, Clostridium Difficile Toxin | 6 |
| LYR | Helicobacter Pylori | 5 |
| GMI | Antigen, Cf And / Or Id, Coccidioides Immitis | 4 |
| GMJ | Antigens, Histoplasma Capsulatum, All | 4 |
| GMK | Antiserum, Positive Control, Histoplasma Capsulatum | 4 |
| GMH | Antiserum, Positive Control, Coccidioides Immitis | 3 |
| IGG | Formaldehyde (Formalin, Formol) | 3 |
| KEQ | Media, Mounting, Water Soluble | 3 |
| LIQ | Enzyme Linked Immunoabsorbent Assay, Rotavirus | 3 |
| DHR | System, Test, Rheumatoid Factor | 2 |
| GMD | Antisera, Latex Agglutination, Cryptococcus Neoformans | 2 |
| GNA | Antisera, All Types, Escherichia Coli | 2 |
| JWW | Antigen, Cf, B. Dermatitidis | 2 |
| JWZ | Kit, Screening, Trichomonas | 2 |
| KFG | Antiserum, Positive Control, Aspergillus Spp. | 2 |
| KFH | Antiserum, Positive Control, Blastomyces Dermatitidis | 2 |
| LGC | Enzyme Linked Immunoabsorbent Assay, Herpes Simplex Virus, Non-Specific | 2 |
| LKS | Device, Parasite Concentration | 2 |
| LYF | Pneumocystis Carinii | 2 |
| MCB | Antigen, C. Difficile | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 10, 1999 | K993914 | PREMIER TOXINS A&B, MODEL 616096 Meridian Diagnostics, Inc. | LLH |
| Aug 9, 1999 | K990263 | IMMUNOCARD STAT! E. COLI O157:H7 Meridian Diagnostics, Inc. | GMZ |
| Jun 25, 1999 | K984346 | PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TEST Meridian Diagnostics, Inc. | LGC |
| Jun 25, 1999 | K984343 | PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TEST Meridian Diagnostics, Inc. | MXJ |
| Dec 17, 1998 | K983255 | MODIFICATION TO: PREMIER PLATINUM HPSA Meridian Diagnostics, Inc. | LYR |
| Dec 3, 1998 | K982764 | PREMIER CRYPTOSPORIDIUM Meridian Diagnostics, Inc. | MHJ |
| Nov 25, 1998 | K982711 | PREMIER GIARDIA Meridian Diagnostics, Inc. | MHI |
| May 12, 1998 | K980076 | PREMIER PLATINUM HPSA Meridian Diagnostics, Inc. | LYR |
| Apr 2, 1998 | K980077 | PARA-PAK SPINCON Meridian Diagnostics, Inc. | LKS |
| Aug 20, 1997 | K971585 | IMMUNOCARD STAT! ROTAVIRUS Meridian Diagnostics, Inc. | LIQ |
| Jan 21, 1997 | K961508 | IMMUNOCARD H. PYLORI Meridian Diagnostics, Inc. | LYR |
| May 23, 1996 | K953839 | PREMIER HSV PLUS Meridian Diagnostics, Inc. | LGC |
| Apr 18, 1996 | K955859 | IMMUNOCARD TOXIN A Meridian Diagnostics, Inc. | LLH |
| Nov 14, 1995 | K953362 | PREMIER EHEC Meridian Diagnostics, Inc. | GNA |
| Apr 14, 1995 | K950167 | PREMIER EHEC Meridian Diagnostics, Inc. | GNA |
| Mar 3, 1995 | K945558 | PREMIER(TM) H. PYLORY Meridian Diagnostics, Inc. | LYR |
| Dec 8, 1994 | K941560 | IMMUNOCARD H. PYLORI Meridian Diagnostics, Inc. | LYR |
| Oct 27, 1994 | K943228 | MICROSPORIDIUM CONTROL SET Meridian Diagnostics, Inc. | LJG |
| Sep 20, 1994 | K934550 | IMMUNOCARD MYCOPLASMA Meridian Diagnostics, Inc. | LJZ |
| Feb 3, 1994 | K933587 | IMMUNOCARD ROTAVIRUS Meridian Diagnostics, Inc. | LIQ |
| Dec 27, 1993 | K930778 | IMMUNOCARD MONO Meridian Diagnostics, Inc. | KTN |
| Jun 15, 1993 | K931770 | PARA-PAK PLUS Meridian Diagnostics, Inc. | LIO |
| Jan 27, 1993 | K926442 | PREMIER C. DIFFICILE, MODIFICATION Meridian Diagnostics, Inc. | LLH |
| Jan 26, 1993 | K924979 | IMMUNOCARD(TM) C. DIFFICILE Meridian Diagnostics, Inc. | LLH |
| Oct 19, 1992 | K924136 | PREMIER C. DIFFICILE TOXIN A CONTROLS Meridian Diagnostics, Inc. | LLH |
| Oct 19, 1992 | K924062 | MERITEC C. DIFFICILE CONTROLS Meridian Diagnostics, Inc. | MCB |
| Oct 5, 1992 | K923859 | PREMIER BLASTOMYCES Meridian Diagnostics, Inc. | MJL |
| Jul 30, 1992 | K915700 | PERMIER HISTOPLASMA Meridian Diagnostics, Inc. | MIZ |
| Jul 10, 1992 | K915493 | PREMIER COCCIDIOIDES Meridian Diagnostics, Inc. | MIY |
| Jul 24, 1991 | K912408 | MERIFLUOR-CRYPTOSPORIDIUM/GIARDIA Meridian Diagnostics, Inc. | MHI |
| Jan 30, 1991 | K905493 | MERISTAR-MP Meridian Diagnostics, Inc. | GSA |
| Jan 25, 1991 | K904393 | PREMIER-CRYPTOCOCCAL ANTIGEN Meridian Diagnostics, Inc. | MDU |
| Oct 16, 1990 | K904400 | MERIFLUOR TM PNEUMOCYSTIS MODIFICATION Meridian Diagnostics, Inc. | LYF |
| Oct 1, 1990 | K903456 | PREMIER-C. DIFFICILE TOXIN A Meridian Diagnostics, Inc. | LLH |
| Mar 12, 1990 | K895915 | MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEM Meridian Diagnostics, Inc. | MCB |
| Sep 8, 1989 | K894845 | (CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASE Meridian Diagnostics, Inc. | GMD |
| Aug 15, 1989 | K894246 | MERIVIEW TM TRICHOMONAS Meridian Diagnostics, Inc. | JWZ |
| May 24, 1989 | K892263 | MERIFLUOR(TM) -TRICHOMONAS Meridian Diagnostics, Inc. | JWZ |
| Aug 4, 1988 | K881608 | MERIFLUOR(TM) PNEUMOCYSTIS Meridian Diagnostics, Inc. | LYF |
| Apr 12, 1988 | K880389 | MERITEC(TM)-CAMPY (JCL) Meridian Diagnostics, Inc. | LQP |
| Dec 9, 1987 | K874078 | MERITEC(TM)-GC Meridian Diagnostics, Inc. | LIC |
| Sep 16, 1987 | K873299 | MERIFLUOR(TM)-GIARDIA Meridian Diagnostics, Inc. | GWD |
| Mar 16, 1987 | K870171 | (MERIFLUOR)TM-CRYPTOSPORIDIUM Meridian Diagnostics, Inc. | |
| Feb 21, 1986 | K860034 | PARA-PAK MACRO-CON Meridian Diagnostics, Inc. | LKS |
| Jul 18, 1985 | K850269 | MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURE Meridian Diagnostics, Inc. | LIQ |
| Aug 11, 1983 | K831599 | MERITEC-STREP GROUP A BETA-HEMOLYTIC Meridian Diagnostics, Inc. | GTY |
| May 13, 1982 | K821100 | MERITECASTREP (TM) Meridian Diagnostics, Inc. | GTZ |
| Apr 14, 1982 | K820531 | ENDO-STAPH TEICHOIC ACID ANTIBODY KIT Meridian Diagnostics, Inc. | LHT |
| Nov 10, 1981 | K812817 | NEUTRAL DUFFERED FORMA-SCENT Meridian Diagnostics, Inc. | IFP |
| Jul 15, 1981 | K811722 | PARA-PAK Meridian Diagnostics, Inc. | HYI |
Newest 50 of 92.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||