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510(k) K950211

ELSA-PTH by Cis-Us, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 13, 1995
Date Received
January 19, 1995
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 Cis-Us, Inc.

  • K951708 — ELSA-HCT (September 5, 1995)
  • K890799 — CURIETRON 192 HIGH DOSE RATE (October 27, 1989)
  • K882449 — CESIUM 137 SOURCE, MODEL CSM-40 (April 14, 1989)
  • K871502 — PERSONNEL PROTECTIVE SHIELD (May 8, 1987)
  • K865027 — IRRADIATOR FOR BIOLOGICAL MATERIALS, IBL-137C (February 26, 1987)
  • K863778 — VENTICIS II (October 27, 1986)
  • K860823 — ELSA-PROL IMMUNORADIOMETRIC ASSAY KIT (August 19, 1986)
  • K860824 — TSHK-NN RIA KIT (April 28, 1986)

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  • 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)