510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Meridian Diagnostics, Inc.

Walker, MI, US

Meridian Diagnostics, Inc. appears in FDA device records in Walker, MI. FDA records list 92 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.

FDA records held for this company

510(k) clearances
92
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 92

FDA records hold 92 510(k) clearances for Meridian Diagnostics, Inc. between 1980 and 1999. The busiest year on record is 1980, with 41. The most recent is 1999, with 4.

Clearances by year, as a table
510(k) clearance decisions for Meridian Diagnostics, Inc., by decision year
YearClearances
198041
19813
19822
19831
19851
19861
19873
19882
19893
19903
19913
19925
19934
19944
19953
19962
19972
19985
19994
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K993914PREMIER TOXINS A&B, MODEL 616096LLHSubstantially Equivalent
K990263IMMUNOCARD STAT! E. COLI O157:H7GMZSubstantially Equivalent
K984346PREMIER TYPE SPECIFIC HSV-2 IGG ELISA TESTLGCSubstantially Equivalent
K984343PREMIER TYPE SPECIFIC HSV-1 IGG ELISA TESTMXJSubstantially Equivalent
K983255MODIFICATION TO: PREMIER PLATINUM HPSALYRSubstantially Equivalent
K982764PREMIER CRYPTOSPORIDIUMMHJSubstantially Equivalent
K982711PREMIER GIARDIAMHISubstantially Equivalent
K980076PREMIER PLATINUM HPSALYRSubstantially Equivalent
K980077PARA-PAK SPINCONLKSSubstantially Equivalent
K971585IMMUNOCARD STAT! ROTAVIRUSLIQSubstantially Equivalent
K961508IMMUNOCARD H. PYLORILYRSubstantially Equivalent
K953839PREMIER HSV PLUSLGCSubstantially Equivalent
K955859IMMUNOCARD TOXIN ALLHSubstantially Equivalent
K953362PREMIER EHECGNASubstantially Equivalent
K950167PREMIER EHECGNASubstantially Equivalent
K945558PREMIER(TM) H. PYLORYLYRSubstantially Equivalent
K941560IMMUNOCARD H. PYLORILYRSubstantially Equivalent
K943228MICROSPORIDIUM CONTROL SETLJGSubstantially Equivalent
K934550IMMUNOCARD MYCOPLASMALJZSubstantially Equivalent
K933587IMMUNOCARD ROTAVIRUSLIQSubstantially Equivalent
K930778IMMUNOCARD MONOKTNSubstantially Equivalent
K931770PARA-PAK PLUSLIOSubstantially Equivalent
K926442PREMIER C. DIFFICILE, MODIFICATIONLLHSubstantially Equivalent
K924979IMMUNOCARD(TM) C. DIFFICILELLHSubstantially Equivalent
K924136PREMIER C. DIFFICILE TOXIN A CONTROLSLLHSubstantially Equivalent
K924062MERITEC C. DIFFICILE CONTROLSMCBSubstantially Equivalent
K923859PREMIER BLASTOMYCESMJLSubstantially Equivalent
K915700PERMIER HISTOPLASMAMIZSubstantially Equivalent
K915493PREMIER COCCIDIOIDESMIYSubstantially Equivalent
K912408MERIFLUOR-CRYPTOSPORIDIUM/GIARDIAMHISubstantially Equivalent
K905493MERISTAR-MPGSASubstantially Equivalent
K904393PREMIER-CRYPTOCOCCAL ANTIGENMDUSubstantially Equivalent
K904400MERIFLUOR TM PNEUMOCYSTIS MODIFICATIONLYFSubstantially Equivalent
K903456PREMIER-C. DIFFICILE TOXIN ALLHSubstantially Equivalent
K895915MERITEC(TM) - C. DIFFICILE LATEX TEST SYSTEMMCBSubstantially Equivalent
K894845(CALAS(TM)) W/ADD'L REAGENT CALAS(TM) PRONASEGMDSubstantially Equivalent
K894246MERIVIEW TM TRICHOMONASJWZSubstantially Equivalent
K892263MERIFLUOR(TM) -TRICHOMONASJWZSubstantially Equivalent
K881608MERIFLUOR(TM) PNEUMOCYSTISLYFSubstantially Equivalent
K880389MERITEC(TM)-CAMPY (JCL)LQPSubstantially Equivalent
K874078MERITEC(TM)-GCLICSubstantially Equivalent
K873299MERIFLUOR(TM)-GIARDIAGWDSubstantially Equivalent
K870171(MERIFLUOR)TM-CRYPTOSPORIDIUMSubstantially Equivalent
K860034PARA-PAK MACRO-CONLKSSubstantially Equivalent
K850269MERITEC-TOTAVIRUS LATEX DETECTION PROCEDURELIQSubstantially Equivalent
K831599MERITEC-STREP GROUP A BETA-HEMOLYTICGTYSubstantially Equivalent
K821100MERITECASTREP (TM)GTZSubstantially Equivalent
K820531ENDO-STAPH TEICHOIC ACID ANTIBODY KITLHTSubstantially Equivalent
K812817NEUTRAL DUFFERED FORMA-SCENTIFPSubstantially Equivalent
K811722PARA-PAKHYISubstantially Equivalent

Registered establishments

No FDA establishment registrations recorded against this company.

FDA product codes

Recall records

No recall records for this company in the ingested FDA data.

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain