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

Mchenry, IL, US

Macomb Chemical Co. 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 Macomb Chemical Co. between 1977 and 1983. The busiest year on record is 1978, with 6. The most recent is 1983, with 2.

Clearances by year, as a table
510(k) clearance decisions for Macomb Chemical Co., by decision year
YearClearances
19773
19786
19796
19805
19811
19832
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K830095RAPID CHEM ANALYZER IIJJFSubstantially Equivalent
K823720SPECTROPHOTOMETERJJQSubstantially Equivalent
K810958GLYCOHEMOGLOBINLCPSubstantially Equivalent
K801086P-NITROPHENYL PHOSPHATESubstantially Equivalent
K800719ENZYMATIC UREA NITROGEN REAGENT SET REVICDQSubstantially Equivalent
K800720MACOMB NAD-NICOTINAMIDE ADENINE DINUCLEOSubstantially Equivalent
K792533CREATINE PHOSPHOKINASE (CPK) REAGENT SETJHWSubstantially Equivalent
K792532GLUCOSE (HEXOKINASE) REAGENT SETCFRSubstantially Equivalent
K791669GLUCOSE OXIDASE REAGENT SETCGASubstantially Equivalent
K791511ENZYMATIC REAGENT SET, 4X250 ML.CHHSubstantially Equivalent
K791119MACOMB NORMAL CONTROL SERUMJJYSubstantially Equivalent
K790947AUTO ENZYMATIC CHOLESTEROLCHHSubstantially Equivalent
K790371MACOMB LIPID CONTROLJJYSubstantially Equivalent
K790065ALKALINE PHOSPHATASECJESubstantially Equivalent
K781128LDH (UV KINETIC)CFJSubstantially Equivalent
K780447URIC ACID REFERENCE SERAJITSubstantially Equivalent
K780659HDL CHOLESTEROLCHHSubstantially Equivalent
K780534UREA NITROGEN (ENZYMATIC)CDQSubstantially Equivalent
K780351NORMAL UNASSAYED CONTROL SERAJJYSubstantially Equivalent
K780013SERUM GLUTAMIC OXALOACETIC TRANSAMINASECITSubstantially Equivalent
K771820ENZYMATIC CHOLESTEROLCHHSubstantially Equivalent
K770993TRIGLYCERIDE REAGENT SETCDTSubstantially Equivalent
K770991SERUM GLUTAMIC PYRUVIC TRANSAMINASECKASubstantially 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