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510(k) K842499

NMS 1043 ENZYME IMMUNOASSAY KIT by Nms Pharmaceuticals, Inc. — Product Code JHI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1984
Date Received
June 26, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Visual, Pregnancy Hcg, Prescription Use
Device Class
Class II
Regulation Number
862.1155
Review Panel
CH
Submission Type

Other clearances by Nms Pharmaceuticals, Inc.

  • K861202 — TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS (January 9, 1987)
  • K854236 — HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS (October 10, 1986)
  • K860828 — FORETEL, COLOR OVULATION TEST (August 4, 1986)
  • K853925 — QUANTITATIVE DETERMINATION OF HCG IN SERUM-ELISA (December 2, 1985)
  • K851445 — COLOR OVULATION TEST (July 29, 1985)
  • K850431 — EZ-DETECT VISUAL COLOR TEST FOR BLOOD IN STOOL (June 17, 1985)
  • K850786 — TOTAL HIGE ENZYME IMMUNOASSAY (April 12, 1985)
  • K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (March 26, 1985)

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  • K130456 — WUNDER PREGNANCY TEST (April 8, 2014)
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  • K131166 — SOFIA(R) HCG FIA (August 2, 2013)
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  • K112101 — FASTEP HCG PREGANCY SERUM/URINE CASSETTE AND DIPSTICK TESTS (July 17, 2012)