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510(k) K812194

IMMUNODIFFUSION BAND INTENSIFYING FLUID by American Scientific Products — Product Code JZS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 1981
Date Received
August 3, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrophoresis Instrumentation
Device Class
Class I
Regulation Number
866.4500
Review Panel
IM
Submission Type

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  • K831625 — UREA NITROGEN-BUN-REAGENTS B6360-12 (July 7, 1983)
  • K831628 — CREATININE REAGENTS B6370-13 (July 6, 1983)
  • K831624 — GLUCOSE REAGENT KITS-B6370-10A (July 6, 1983)
  • K831627 — CREATININE REAGENTS B6360-10 (July 6, 1983)
  • K831571 — ROTOR (June 30, 1983)
  • K831569 — REAGENT CUPS (June 30, 1983)

Other clearances for product code JZS

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  • K770150 — ELECTRO IMMUNO ASSAY KIT (February 1, 1977)