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510(k) K023304

IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODEL L2KCL by Diagnostic Products Corp. — Product Code JKR

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 9, 2002
Date Received
October 3, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Calcitonin
Device Class
Class II
Regulation Number
862.1140
Review Panel
CH
Submission Type

Other clearances by Diagnostic Products Corp.

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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)
  • 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)
  • K021208 — IMMULITE 2000 MIXED ALLERGEN PANELS (May 30, 2002)

Other clearances for product code JKR

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  • K060578 — CALCITONIN IMMUNORADIOMETRIC ASSAY (IRMA) (COATED TUBE VERSION) (August 30, 2006)
  • K990073 — CALCITONIN (May 11, 1999)
  • K982491 — SANGUI BIOTECH, INC. CALCITONIN ELISA KIT (September 3, 1998)
  • K964635 — NICHOLS ADVANTAGE CHEMILUMINESCENCE CALCITONIN KIT (May 21, 1997)
  • K961043 — SCANTIBODIES CALCITONIN IMMUNORADIOMETRIC ASSAY (COATED BEAD TECHNOLOGY) (May 6, 1996)
  • K945961 — CALCITONIN IMMUNOASSAY KIT (November 20, 1995)
  • K951708 — ELSA-HCT (September 5, 1995)
  • K914429 — DSL ULTRA-SENSITIVE CALCITONIN RIA (DSL 5200) (January 15, 1992)