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510(k) K821131

RADIOIMMUNOASSAY PARATHYROID HORMONE MID by Endocrine-Metabolic Center — Product Code CEW

K821131 is an FDA 510(k) premarket notification submitted by Endocrine-Metabolic Center for the device "RADIOIMMUNOASSAY PARATHYROID HORMONE MID". The FDA issued a decision of Substantially Equivalent on June 2, 1982. The device falls under product code CEW (Radioimmunoassay, Parathyroid Hormone), a Class II device regulated under 21 CFR 862.1545. Endocrine-Metabolic Center has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 2, 1982
Date Received
April 20, 1982
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 Endocrine-Metabolic Center

  • K811993 — RADIOIMMUNOASSAY, FOLLICLE STIMULATING (August 3, 1981)
  • K811994 — RADIOIMMUNOASSAY LUTEINIZING HORMONE (July 27, 1981)
  • K810948 — RADIOIMMUNOASSAY THYROID STIM. HORM. KIT (April 17, 1981)
  • K810351 — RADIOIMMUNOASSAY, TOTAL TRIIODOTHRONIE (February 23, 1981)
  • K800187 — EMC-M-175, THYROXINE - 100 TUBES (February 13, 1980)
  • K800188 — EMC-M-180, T3 UPTAKE - 100 TUBES (February 13, 1980)
  • K790602 — RIA, DIGNXIN-125-I (July 30, 1979)
  • K790630 — RIA, INSULIN, DOUBLE ANTIBODY (July 24, 1979)

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