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

Mchenry, IL, US

Kallestad Laboratories, Inc. appears in FDA device records in Mchenry, IL. 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 Kallestad Laboratories, Inc. between 1976 and 1986. The busiest year on record is 1977, with 22. The most recent is 1986, with 14.

Clearances by year, as a table
510(k) clearance decisions for Kallestad Laboratories, Inc., by decision year
YearClearances
19762
197722
19788
19797
19803
198115
198211
19831
19843
19856
198614
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K863681PATHFINDER(TM) DIRECT ANTIGEN DETECTION SYSTEMLJPSubstantially Equivalent
K862917PATHFINDER ROTAVIRUS CHEMILUMINESCENTLIQSubstantially Equivalent
K863682PATHFINDER(TM) SPECIMEN COLLECTION KITJSMSubstantially Equivalent
K862743PATHFINDER(TM) RESPIRATORY SYNCYTIAL VIRUSGQGSubstantially Equivalent
K862313KALLESTAD SM/RNP TEST REAGENTLKJSubstantially Equivalent
K862710KALLESTAD SSA/SSB ENA TEST REAGENTSLLLSubstantially Equivalent
K855014QUANTIMETRIC PLUS CALIBRATOR/CONTROL SET AJIXSubstantially Equivalent
K855010QUANTIMETRIC PLUS IGM REAGENT KITDFTSubstantially Equivalent
K855013QUANTIMETRIC PLUS SUPPORT PACKDEHSubstantially Equivalent
K855012QUANTIMETRIC PLUS C4 REAGENT KITDBISubstantially Equivalent
K855011QUANTIMETRIC PLUS C3 REAGENT KITCZNSubstantially Equivalent
K855009QUANTIMETRIC PLUS IGA REAGENT KITCZPSubstantially Equivalent
K855008QUANTIMETRIC PLUS KAPPA REAGENT KITDFHSubstantially Equivalent
K855007QUANTIMETRIC PLUS LAMBDA REAGENT KITDEHSubstantially Equivalent
K854483KALLESTAD QUANTIMETRIC PLUS IGG REAGENT KITKTOSubstantially Equivalent
K853554PATHFINDER DIRECT ANTIGEN DETECTION SYS ROTAVIRUSLIQSubstantially Equivalent
K852999QVANTIMETRIC 2KAPPA AND LAMBDA TEST KITDEHSubstantially Equivalent
K852794ALLERCOAT ALLERGEN DISCSDHBSubstantially Equivalent
K852125PATHFINDER DETECTION & COLLECTION KITS-HERPES SIMPGQLSubstantially Equivalent
K852268QUANTICLONE IGE RADIOIMMUNASSAYDGCSubstantially Equivalent
K841864QUANTIMETRIC TM 2 KAPPA & LAMBDA KITDEHSubstantially Equivalent
K842125ALLERCOAT ALLERGEN DISCSDGCSubstantially Equivalent
K840360ALLERCOAT MULTISCREEN DISCSDHBSubstantially Equivalent
K831326ALLERCOAT ALLERGEN DISCSDGCSubstantially Equivalent
K823470ALLERCOAT ALLERGEN DISCSDHBSubstantially Equivalent
K823403ALLERCOAT POSITIVE CONTROL SERUMDGCSubstantially Equivalent
K823107QUANTIMETRIC 2 CERULOPLASMIN ASSAYDDBSubstantially Equivalent
K822613RAST ALLERCOAT ALLERGEN DISCSDGCSubstantially Equivalent
K822206TOTAL IGE DISCSDGCSubstantially Equivalent
K822133IGE/THE OPHYLLINE CONTROL SERUM I,II,IIIJJYSubstantially Equivalent
K821984QUANTIMETRIC 2 C-REACTIVE PROTEIN REAG.DCKSubstantially Equivalent
K821862QUANTICOAT 125 I-THEOPHYLLINE RADIOIMM.LCASubstantially Equivalent
K812416MARK 500 SYSTEMSubstantially Equivalent
K820029KALLESTAD RAST REAGENTSDHBSubstantially Equivalent
K813592QUANTAFLUOR FLUORESCENT TEST REAGENTSDHNSubstantially Equivalent
K813242QUANTIMETRIC 2 TEST KITKEWSubstantially Equivalent
K812411IMMUNO-CELL IMMUNO-SEP KITJCFSubstantially Equivalent
K812611QUANTICOAT NEONATAL 125 T4 RADIOIMMUNOCDPSubstantially Equivalent
K812414KALLESTAD 125I ANTISERUM TO HUMAN IGEDHBSubstantially Equivalent
K812415KALLESTAD ANTISERA TO TOBRAMYCINKLBSubstantially Equivalent
K812327KAPPA & LAMBDA BENCE JONES CONTROLSCZQSubstantially Equivalent
K812050KALLESTAD ANTISERA TO GENTAMICINDJISubstantially Equivalent
K811740KALLESTAD'S ENDOPLATE FACTOR B TESTJZHSubstantially Equivalent
K811776KALLESTAD QUANTICOAT 125 DIGOXINDPOSubstantially Equivalent
K811775KALLESTAD ANTISERA TO PHENYTOINDLPSubstantially Equivalent
K811617QUANTIMETRIC C-REACTIVE PROTEIN ASSAY R.DCKSubstantially Equivalent
K811545KALLESTAD QUANTITOPE LOW LEVEL IGE REAGDGCSubstantially Equivalent
K811445KALLESTAD R QUANTIPLATE ALT. PATHWAY T.DHLSubstantially Equivalent
K811367KALLESTAD ANTISERA TO PHENOBARBITALDLZSubstantially Equivalent
K810863KALLESTAD HEP-2 CELL LINE SUBSTRATEDBMSubstantially 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.

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