FDA 510(k), K843758, UROPAPER EIKEN GK
FDA 510(k), K843758, UROPAPER EIKEN GK
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510(K) Number: K843758
Device Name: UROPAPER EIKEN GK
Manufacturer: SYN-KIT, INC.
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 09/25/1984
Decision Date: 12/18/1984
Regulation Medical Specialty: Clinical Chemistry
Device Name: UROPAPER EIKEN GK
Manufacturer: SYN-KIT, INC.
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 09/25/1984
Decision Date: 12/18/1984
Regulation Medical Specialty: Clinical Chemistry