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

Mchenry, IL, US

Coulter Electronics, Inc. appears in FDA device records in Mchenry, IL. FDA records list 101 510(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
101
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 101

FDA records hold 101 510(k) clearances for Coulter Electronics, Inc. between 1976 and 1994. The busiest year on record is 1984, with 13. The most recent is 1994, with 1.

Clearances by year, as a table
510(k) clearance decisions for Coulter Electronics, Inc., by decision year
YearClearances
19766
19775
19786
19798
19806
19822
19832
198413
19859
19864
19878
19888
19893
199010
19914
19925
19931
19941
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K923951CD8 CYTOSPHERES KITMAMSubstantially Equivalent
K930119COULTER RETIC-C CELL CONTROLJPKSubstantially Equivalent
K921279CD4 CYTOSPHERES KITGKZSubstantially Equivalent
K923530COULTER MULTI-Q-PREPGKHSubstantially Equivalent
K922181COULTER MH009GKZSubstantially Equivalent
K922704COULTER MAXM W/ AUTOLOADERGKZSubstantially Equivalent
K921567COULTER MH017GKZSubstantially Equivalent
K912133PX COULTER(R) CELL CONTROLJPKSubstantially Equivalent
K911385COULTER(R) MH010GKZSubstantially Equivalent
K905771COULTER DART AST (GOT) REAGENTCITSubstantially Equivalent
K905767COULTER DART ALT (GPT) REAGENTCKASubstantially Equivalent
K905622COULTER DIRECT BILLRUBIN REAGENTCIGSubstantially Equivalent
K904866COULTER CK-MB ISOENZYME REAGENTJHTSubstantially Equivalent
K897162COULTER CHOLESTEROL REAGENTCHHSubstantially Equivalent
K897164COULTER LD (LDH-L) REAGENTCFJSubstantially Equivalent
K897163COULTER ALT (GPT) REAGENTCKASubstantially Equivalent
K897160COULTER GLUCOSE REAGENTCFRSubstantially Equivalent
K897159COULTER TRIGLYCERIDES GPO REAGENTCDTSubstantially Equivalent
K897161COULTER URIC ACID REAGENTKNKSubstantially Equivalent
K897166COULTER TOTAL PROTEIN REAGENTCEKSubstantially Equivalent
K897165COULTER AST (GOT) REAGENTCITSubstantially Equivalent
K894836DART UREA NITROGENCDQSubstantially Equivalent
K885332COULTER FLOW RETICULOCYTE REAGENTGKLSubstantially Equivalent
K885028COULTER 5P CONTROLGKZSubstantially Equivalent
K885093COULTER STKSGKZSubstantially Equivalent
K883503COULTER VISCOMETER IIJJLSubstantially Equivalent
K883055DART CARBON DIOXIDEKHSSubstantially Equivalent
K880294DART PHENYTOINLFOSubstantially Equivalent
K880507COULTER VCS LEUKOCYTE DIFFERENTIAL COUNTERGKZSubstantially Equivalent
K875047COULTER CLONE T11 MONOCLONAL ANTIBODYGKZSubstantially Equivalent
K874838COULTER COUNTER MODEL T SERIES W/2-PART DIFFERENT.GKZSubstantially Equivalent
K874188COULTER IMMUNOPREP LEUKOCYTE/Q-PREP IMMUNO WRK STAGKMSubstantially Equivalent
K874185DART (R) ELECTROLYTE REAGENT SYSTEMJGSSubstantially Equivalent
K872041COULTER DART CK-MB ISOENZYME REAGENT SYSTEMJHTSubstantially Equivalent
K871837COULTER COUNTER MODEL S-PLUS STKRGKZSubstantially Equivalent
K862122S-CAL HEMATOLOGY CALIBRATORKRYSubstantially Equivalent
K870736DART THEOPHYLLINE REAGENT SYSTEMKLSSubstantially Equivalent
K864802DART DIGOXIN ASSAYLCSSubstantially Equivalent
K864611IMMUNO-SURESubstantially Equivalent
K864612DART PHENOBARBITAL ASSAY SYSTEMLFNSubstantially Equivalent
K863085COULTER COUNTER MODEL T-540GKLSubstantially Equivalent
K863084COULTER COUNTER MODEL T-890GKLSubstantially Equivalent
K861780COULTER COUNTER MODEL S PLUS JUNIORGKLSubstantially Equivalent
K862370DART AMYLASE-D.S. REAGENT SYSTEMCIJSubstantially Equivalent
K854708DART CK-MB REAGENT SYSTEMJHSSubstantially Equivalent
K854305DART IRON & IRON BINDING CAPACITY REAGENTCFMSubstantially Equivalent
K854114COULTER COUNTER MODEL T-660GKLSubstantially Equivalent
K853429COULTER COUNTER MODEL M5GKLSubstantially Equivalent
K851943COULTER VOLUME ADAPTERGKLSubstantially Equivalent
K851736COULTER CHANNELYZER 256GKLSubstantially 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