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510(k) K782081

RIA SYSTEM, PARATHYROID HORMONE by Iso-Tex Diagnostics — Product Code CEW

K782081 is an FDA 510(k) premarket notification submitted by Iso-Tex Diagnostics for the device "RIA SYSTEM, PARATHYROID HORMONE". The FDA issued a decision of Substantially Equivalent on March 21, 1979. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Iso-Tex Diagnostics has at least 2 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 21, 1979
Date Received
December 13, 1978
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 Iso-Tex Diagnostics

  • K851389 — APO B RIA KIT (July 10, 1985)
  • K840105 — APO A-I RIA KIT-HUMAN PLASMA APOLIP- (January 10, 1984)

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