510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN

Harleco

Mchenry, IL, US

Harleco appears in FDA device records in Mchenry, IL. FDA records list 116 510(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
116
PMA records
0
Recall records
0
Registered establishments
0

510(k) clearance history

Showing 50 of 116

FDA records hold 116 510(k) clearances for Harleco between 1976 and 1982. The busiest year on record is 1977, with 47. The most recent is 1982, with 1.

Clearances by year, as a table
510(k) clearance decisions for Harleco, by decision year
YearClearances
197620
197747
197821
198127
19821
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K820233ULTRAZYME PLUS GAMMA GT(65055-65056)JQBSubstantially Equivalent
K813427ULTRACHEM GLUC-DHLFRSubstantially Equivalent
K813044ULTRACHEM ALB, ITEM #64970CIXSubstantially Equivalent
K813043ULTRACHEM CREA ITEM #64972CGXSubstantially Equivalent
K813042ULTRACHEM GLUC-DH SET, ITEM #65048LFRSubstantially Equivalent
K813041ULTRAZYME-GT, ITEM #64959 & 65032JQBSubstantially Equivalent
K813040ULTRACHEM CA, ITEM #64975CJYSubstantially Equivalent
K813039ULTRACHEM E-CHOL, ITEM #65025CHHSubstantially Equivalent
K813038ULTRACHEM TP, ITEM #64974CEKSubstantially Equivalent
K812594ULTRA ZYME PLUS AMYL #64982 & 65031CIJSubstantially Equivalent
K812593ULTRA ZYME PLUS CK-1 #64978, 65027 & 28CGSSubstantially Equivalent
K812596ULTRA ZYME PLUS ALP #64962, 65029 & 30CJESubstantially Equivalent
K812595ULTRA CHEM E-GLU #64976 & 65040CFRSubstantially Equivalent
K812592ULTRA ZYME PLUS GOT #64953, 65033 & 34CITSubstantially Equivalent
K812591ULTRA ZYME PLUS GPT, #64956, 65035 & 36CKASubstantially Equivalent
K812590ULTRA ZYME PLUS LDH #64950, 65038 & 39CFJSubstantially Equivalent
K812589ULTRA CHEM E-TRIG #65024CDTSubstantially Equivalent
K812500ULTRACHEM URIC ACID ALDH, ITEM #65047CDOSubstantially Equivalent
K812258ACR ENZYMATIC GLUCOSE OXIDASECGASubstantially Equivalent
K811576CARDIOZYME PLUS CK-TOTAL ITEM #65046 (A)CGSSubstantially Equivalent
K811575CARDIOZYME PLUS CK-MB ITEM #65045 (G)JHWSubstantially Equivalent
K811574CARDIOZYME PLUS CK-TOTAL ITEM #65046CGSSubstantially Equivalent
K811573CARDIOZYME PLUS CK-MB ITEM #65045JHWSubstantially Equivalent
K811202ULTRACHEM GLUC-DH, ITEM NO. 65048LFRSubstantially Equivalent
K810684HEMOCOLOR STAIN SETICCSubstantially Equivalent
K810725QUALITROL #65057JJTSubstantially Equivalent
K803169CARDIOZYME PLUS CK-TOTAL #65046JHSSubstantially Equivalent
K803168CARDIO ZYME PLUS CK-MB #65045JHWSubstantially Equivalent
K780829SYSING AND HEMOGLOBIN REAGENTGKRSubstantially Equivalent
K780830ISOTONIC BUFFERED SALINEGIFSubstantially Equivalent
K780524ULTRACHEM T-BILI 64971 GILFORD 3500CIGSubstantially Equivalent
K780523ULTRACHEM ENZYMATIC CHOLESTEROL 65025CHHSubstantially Equivalent
K780515ULTRACHEM E-GLU, 300 SERIES CENTRIFUCHEMCFRSubstantially Equivalent
K780514ULTRACHEM CREATININE 64972, CENTRIFUCHEMCGXSubstantially Equivalent
K780513ULTRA ZYME PLUS AMYL 64982, GILFORD 3500CIJSubstantially Equivalent
K780172TRIGLYCERIDE INSTRUMENT APPLICATIONCDTSubstantially Equivalent
K780141ULTRAZYME PLUS AMYL, CENTRIFICHEM APPLI.CIJSubstantially Equivalent
K780100ULTRAZYME PLUS CK-1CGSSubstantially Equivalent
K780099ULTRAZYME PLUS GTJPZSubstantially Equivalent
K780101ULTRAZYME PLUS LDHCFJSubstantially Equivalent
K780104ULTRAZYME PLUS HBDJMKSubstantially Equivalent
K780103ULTRAZYME PLUS GOTCITSubstantially Equivalent
K780102ULTRAZYME PLUS GPTCKASubstantially Equivalent
K780095ULTRAZYME PLUS ALPCJESubstantially Equivalent
K780094IRON BINDING CAPACITY CHEMISTRYJMOSubstantially Equivalent
K780093GLUCOSE REAGENT FOR GLUCOSE ANALYZERCGASubstantially Equivalent
K780092ULTRACHEM ALBUMINCIXSubstantially Equivalent
K780065ULTRACHEM E-GLU, MANUAL DETERM.CFRSubstantially Equivalent
K772258CLINICARD CK-IICGSSubstantially Equivalent
K772157CREATININE, 64972CGXSubstantially 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

There is no verification record for this company. Most companies on this site have none: a record exists only where a company asked to be verified and MDM ran the checks, so the absence of one says nothing about the company.

Where there is a record, this is where it appears: what was checked, when it was checked, and the current status. An MDM Verified badge on another website links to a verify address on this domain that resolves to this section. A badge that does not resolve here is not ours.

What MDM checks, and what it does not

MDM coverage

MDM coverage of this company lists here, newest first. Submit news.

Is this your company?

This page is built from public FDA records. Company pages are free and factual, and stay free whether or not anyone claims them. Membership never changes editorial coverage or vetting outcomes.

Claiming lets Harleco edit what it says about itself and list the categories it works in. It grants no badge: claiming is not verification.

The self-serve claim needs an FDA establishment registration, FEI or owner-operator number on the company’s record, and we hold none for Harleco. The only route for a company with no identifier on record is a person here: write to us, and one looks at the record and sends the same claim link by hand.

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