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510(k) K013566

IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6 by Diagnostic Products Corp. — Product Code CEW

K013566 is an FDA 510(k) premarket notification submitted by Diagnostic Products Corp. for the device "IMMULITE INTACT PTH, IMMULITE 2000 INTACT PTH, MODELS LKPP1 (100 TESTS), LKPP5 (500 TESTS), L2KPP2 (200 TESTS), L2KPP6". The FDA issued a decision of Substantially Equivalent on Nov 20, 2001. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Diagnostic Products Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
Nov 20, 2001
Date Received
Oct 26, 2001
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Radioimmunoassay, Parathyroid Hormone
Device Class
Class II
Regulation Number
862.1545
Review Panel
CH
Submission Type

Other clearances by Diagnostic Products Corp.

  • K063045 — IMMULITE 2000, IMMULITE 2500 VANCOMYCIN (Dec 5, 2006)
  • K034055 — IMMULITE 2500 CK-MB, 2500 MYOGLOBIN, 2500 STAT TROPONIN I (Jan 21, 2004)
  • K033234 — IMMULITE 2500 AUTOMATED IMMUNOASSAY ANALYZER (Dec 12, 2003)
  • K032881 — IMMULITE/IMMULITE 1000 TOTAL TESTOSTERONE AND IMMULITE 2000 TOTAL TESTOSTERONE (Oct 10, 2003)
  • K023152 — IMMULITE 2000 ALLERGEN-SPECIFIC IGE (Dec 17, 2002)
  • K023304 — IMMULITE/IMMULITE 1000 CALCITONIN, MODEL LKCL AND IMMULITE 2000 CALCITONIN, MODE (Dec 9, 2002)
  • K022603 — IMMULITE 1000 AUTOMATED IMMUNOASSAY ANALYZER (Aug 21, 2002)
  • K022118 — IMMULITE TURBO CK-MB, MODELS LSKCP1 (100 TESTS), LSKCP5 (500 TESTS) (Jul 22, 2002)
  • K021257 — ANA LINE BLOT, CATALOG NUMBER: KALABI (20 TESTS) (Jun 3, 2002)
  • K021206 — IMMULITE 2000 SPECIFIC ALLERGENS (May 30, 2002)

Other clearances for product code CEW

  • K231927 — Elecsys PTH , Elecsys PTH STAT (Mar 22, 2024)
  • K232791 — Access Intact PTH (Mar 1, 2024)
  • K221197 — VITROS Immunodiagnostic Products Intact PTH II Reagent Pack (Sep 5, 2023)
  • K190702 — Lumipulse G whole PTH (Aug 30, 2019)
  • K163658 — ADVIA Centaur Intact Parathyroid Hormone (PTH) Assay (May 23, 2017)
  • K161158 — IDS-iSYS Intact PTHN (Jan 31, 2017)
  • K150879 — LIASON 1-84 PTH Assay, LIASON 1-84 PTH Control Set, LIASON 1-84 PTH Calibration (Jun 22, 2015)
  • K133601 — ADVIA CENTAUR INTACT PARATHYROID HORMONE (IPTH) ASSAY (Feb 5, 2014)
  • K132515 — LIAISON N-TACT PTH GEN II, CONTROL SET, CALIBRATION VERIFIERS (Nov 8, 2013)
  • K121981 — ADVIA CENTAUR INACT PARATHYROID HORMONE (IPTH) ASSAY (Mar 21, 2013)

FDA data resources