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510(k) K761311

ACCRAASSAY RID KITS by Miles Laboratories, Inc. — Product Code JZQ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 30, 1976
Date Received
December 23, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Plates And Equipment, Radial Immunodiffusion
Device Class
Class I
Regulation Number
866.4800
Review Panel
IM
Submission Type

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  • K870214 — MODIFIED SALTEX REAGENT STRIPS (June 29, 1987)
  • K870752 — SERALYZER LDH/TOTAL BILIRUBIN/TRIGLYCERIDES STRIPS (April 14, 1987)
  • K864530 — SERALYZER GLUCOSE (HK) REAGENT STRIPS,MODULE,CALI. (February 18, 1987)

Other clearances for product code JZQ

  • K881174 — RID PLATE READER (June 8, 1988)
  • K881675 — IMMULON 4 FLAT BOTTOM PLATES & REMOVAWELL STRIPS (April 21, 1988)
  • K831811 — REVOLUTION RADIAL IMMUNODIFFUSION PLATE (July 28, 1983)
  • K792699 — OUCHTERLONY AGAR PLATES (January 24, 1980)
  • K790646 — HELENA QUIPLATE SYSTEM (May 23, 1979)
  • K770548 — IMMUNOPLATE III RADIO IMMUNODIFFUSION (April 15, 1977)