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510(k) K061970

ELECSYS IGE II IMMUNOASSAY by Roche Diagnostics — Product Code JHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 31, 2006
Date Received
July 12, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Immunoglobulins (D, E)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

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Other clearances for product code JHR

  • K984326 — ELECYS IGE ASSAY (February 8, 1999)
  • K960067 — IMMILITE TOTAL IGE (February 14, 1996)
  • K931703 — IMMULITE TOTAL IGE (August 16, 1993)
  • K903000 — TURBO-RAST SPECIFIC IGE ASSAY (July 31, 1990)
  • K901859 — COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 (May 3, 1990)
  • K882616 — ALTERNATE PROCEDURE, PHARMACIA IGE EIA (August 4, 1988)
  • K873077 — PHARMACIA IGE EIA (October 20, 1987)
  • K840103 — RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN (February 10, 1984)