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

Mchenry, IL, US

Harleco Diagnostics appears in FDA device records in Mchenry, IL. FDA records list 23 510(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
23
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

FDA records hold 23 510(k) clearances for Harleco Diagnostics between 1976 and 1982. The busiest year on record is 1982, with 20. The most recent is 1982, with 20.

Clearances by year, as a table
510(k) clearance decisions for Harleco Diagnostics, by decision year
YearClearances
19761
19772
198220
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K823147URIC ACID STANDARD, 8MG/DL #65078JISSubstantially Equivalent
K822852TRIGLYCERIDE CALIBRATORJITSubstantially Equivalent
K822323ULTRACHEM BUN-UV, 65080 & 65081CDWSubstantially Equivalent
K821883ULTRAZYME PLUS CK-ICGSSubstantially Equivalent
K821882ULTRAZYME PLUS GPTCKASubstantially Equivalent
K821881ULTRACHEM CREACGXSubstantially Equivalent
K821880ULTRA CHEM ALBCIXSubstantially Equivalent
K821879ULTRACHEM T.P.CEXSubstantially Equivalent
K821878ULTRAZYME PLUS LDHCFJSubstantially Equivalent
K821877ULTRAZYME PLUS HBDJMKSubstantially Equivalent
K821873ULTRACHEM T-BILICIGSubstantially Equivalent
K821872ULTRACHEM URIC ACID AIDHCDOSubstantially Equivalent
K821871ULTRAZYME PLUS 2GTJPZSubstantially Equivalent
K821876ULTRAZYME PLUS GOTCITSubstantially Equivalent
K821875ULTRACHEM TRI-ESCDTSubstantially Equivalent
K821874ULTRACHEM PHOSCEOSubstantially Equivalent
K821870ULTRAZYME PLUS ALPCJESubstantially Equivalent
K821869ULTRAZYME PLUS AMYLJFJSubstantially Equivalent
K821868ULTRACHEM E-GLUCFRSubstantially Equivalent
K821867ULTRACHEM GLUC-DHLFRSubstantially Equivalent
K770694CPK ULTRAZYME PLUSCGSSubstantially Equivalent
K770613LDH ULTRAZYME PLUSCFJSubstantially Equivalent
K761026AUTO-ALBUMIN REAG FOR GILFORD 3400E ANALCIXSubstantially 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