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510(k) K033727

NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY by Nichols Institute Diagnostics — Product Code CEW

K033727 is an FDA 510(k) premarket notification submitted by Nichols Institute Diagnostics for the device "NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on April 22, 2004. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Nichols Institute Diagnostics has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 22, 2004
Date Received
November 28, 2003
Clearance Type
Traditional
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 Nichols Institute Diagnostics

  • K050784 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (June 1, 2005)
  • K042676 — NICHOLS ADVANTAGE HYPERGLYCOSYLATED HUMAN CHORIONIC GONADOTROPIN (H-HCG) ASSAY (December 17, 2004)
  • K042689 — NICHOLS ADVANTAGE CORTISOL (December 9, 2004)
  • K040813 — NICHOLS ADVANTAGE CHEMILUMINESCENCE INTACT PARATHYROID HORMONE, MODEL 62-7022 (June 8, 2004)
  • K033302 — NICHOLS ADVANTAGE BIO-INTACT PTH (1-84) ASSAY, MODEL 62-7040 (January 26, 2004)
  • K032188 — NICHOLS ADVANTAGE ALDOSTERONE ASSAY (July 31, 2003)
  • K022356 — NICHOLS ADVANTAGE CHEMILUMINESCENCE HELICOBACTOR PYLORI IGG ANTIBODIES IMMUNOASS (October 25, 2002)
  • K022472 — PARATHYROID HORMONE TEST SYSTEM/NICHOLS ADVANTAGE QUICK-INTRAOPERATIVE BIO-INTAC (October 9, 2002)
  • K013992 — NICHOLS ADVANTAGE CHEMILUMINESCENCE BIO-INTACT PARATHYROID HORMONE (1-84) IMMUNO (December 13, 2001)
  • K012367 — VITAMIN D TEST SYSTEM NICHOLS ADVANTAGE 25-HYDROXYVITAMIN D (October 9, 2001)

Other clearances for product code CEW

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

FDA data resources