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510(k) K903130

LONDON DIAGNOSTICS LUMATAG(TM) INTACT PTH ASSAY by London Diagnostics, Inc. — Product Code CEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 25, 1990
Date Received
July 17, 1990
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 London Diagnostics, Inc.

  • K914835 — LUMATAG FREE T4 CHEMILUMINESCENCE ASSAY (December 17, 1991)
  • K911985 — LUMATAG T4 CHEMILUMINESCENCE ASSAY (August 2, 1991)
  • K912858 — LONDON DIAGNOSTICS LUMATAG(R) HGH CHEM IMMUN ASSAY (July 30, 1991)
  • K905814 — LUMATAG(R) FSH CHEMILUMINESCENCE IMMUNOMETRI ASSAY (February 4, 1991)
  • K904458 — LUMATAG(TM) PROLACTIN DIAGNOSTIC KIT/MODIFICATION (October 12, 1990)
  • K902443 — LUMATAG(TM) LH DIAGNOSTIC KIT (August 2, 1990)
  • K903195 — LONDON DIAGNOSTICS LUMATAG (R) IGE CHEM. IMM ASSAY (August 2, 1990)
  • K901484 — LUMATAG(TM) HCG CHEMILUMINESCENCE IMMUNOMETRIC (May 1, 1990)
  • K901075 — LUMATAG(TM) FERRITIN CHEMILUMINESCENCE IMMUNOMET. (April 2, 1990)
  • K881443 — LUMATAG(TM) TSH CHEMILUMINESCENCE IMMUNO. ASSAY (May 27, 1988)

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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)
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