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510(k) K840103

RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN by Techniclone Intl. — Product Code JHR

K840103 is an FDA 510(k) premarket notification submitted by Techniclone Intl. for the device "RADIOIMMUNOASSAY FOR TOTAL IGE HUMAN". The FDA issued a decision of Substantially Equivalent on February 10, 1984. The device falls under product code JHR (Radioimmunoassay, Immunoglobulins (D, E)), a Class II device regulated under 21 CFR 866.5510.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 10, 1984
Date Received
January 10, 1984
Clearance Type
Traditional
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

Other clearances for product code JHR

  • K061970 — ELECSYS IGE II IMMUNOASSAY (August 31, 2006)
  • 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)

FDA data resources