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510(k) K984326

ELECYS IGE ASSAY by Boehringer Mannheim Corp. — Product Code JHR

K984326 is an FDA 510(k) premarket notification submitted by Boehringer Mannheim Corp. for the device "ELECYS IGE ASSAY". The FDA issued a decision of Substantially Equivalent on February 8, 1999. The device falls under product code JHR (Radioimmunoassay, Immunoglobulins (D, E)), a Class II device regulated under 21 CFR 866.5510. Boehringer Mannheim Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 8, 1999
Date Received
December 3, 1998
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 by Boehringer Mannheim Corp.

  • K983047 — ACCU-CHEK HQ SYSTEM (February 5, 1999)
  • K984419 — ELECSYS IGE CALCHECK (February 2, 1999)
  • K984425 — MODIFICATION OF PRECISET SERUM PROTEINS CALIBRATOR (January 20, 1999)
  • K984372 — ELECSYS CALCHECK TROPONIN T (December 14, 1998)
  • K984105 — ELECSYS TROPONIN T STAT TEST (December 8, 1998)
  • K983503 — ROCHE DIAGNOSTICS, BOEHRINGER MANNHEIM CORPORATION INORGANIC PHOSPHORUS REAGENT (December 1, 1998)
  • K983469 — PRECISET SERUM PROTEINS CALIBRATOR (November 25, 1998)
  • K983185 — BOEHRINGER MANNHEIM TINA-QUANT IGE TEST (November 12, 1998)
  • K982948 — ELECSYS PSA, MODEL # ELECSYS 1010 (October 27, 1998)
  • K983510 — CHEMSTRIP 101 URINE ANALYZER (October 27, 1998)

Other clearances for product code JHR

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

FDA data resources