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510(k) K830664

HUMAN INTRACT PARATHYROID HORMONE BY by Immuno Nuclear Corp. — Product Code CEW

K830664 is an FDA 510(k) premarket notification submitted by Immuno Nuclear Corp. for the device "HUMAN INTRACT PARATHYROID HORMONE BY". The FDA issued a decision of Substantially Equivalent on May 9, 1983. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Immuno Nuclear Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1983
Date Received
March 3, 1983
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 Immuno Nuclear Corp.

  • K863743 — BIOTECH'S IGE IMMUNO RESPONSE TEST ISOTOPE UNIT (December 15, 1986)
  • K863973 — ELM ALLERGEN DISC (December 1, 1986)
  • K863844 — IMMUNO BIOTECH'S LAMB'S QUARTERS ALLERGEN DISC (October 29, 1986)
  • K863123 — IMMUNO BIOTECH MUGWART ALLERGEN DISC (October 1, 1986)
  • K863098 — MEADOW FESCUE ALLERGEN DISC (September 15, 1986)
  • K862266 — MAPLE ALLERGEN DISC (August 19, 1986)
  • K862938 — JUNE GRASS ALLERGEN DISC (August 15, 1986)
  • K862265 — COTTONWOOD ALLERGEN DISC (August 15, 1986)
  • K862176 — RUSSIAN THISTLE ALLERGEN DISC (August 15, 1986)
  • K862939 — ORCHARD GRASS ALLERGEN DISC (August 15, 1986)

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