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510(k) K901859

COAT-A-COUNT TOTAL IGE IRMA, CATALOG #IKIE1, IKIE2 by Diagnostic Products Corp. — Product Code JHR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 3, 1990
Date Received
April 24, 1990
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

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  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (December 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (October 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (December 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (December 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (August 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (July 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (June 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

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)
  • 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)