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510(k) K854236

HISTAMINE RIA TEST FOR HISTAMINE BIOLOGICAL FLUIDS by Nms Pharmaceuticals, Inc. — Product Code IAF

Clearance Details

Decision
SN ()
Decision Date
October 10, 1986
Date Received
October 21, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Wright'S Stain
Device Class
Class I
Regulation Number
864.1850
Review Panel
PA
Submission Type

Other clearances by Nms Pharmaceuticals, Inc.

  • K861202 — TRU-LEVEL CONTROL IMMUNOASSAY CONTROLS (January 9, 1987)
  • 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)
  • K842499 — NMS 1043 ENZYME IMMUNOASSAY KIT (September 14, 1984)

Other clearances for product code IAF

  • K890673 — WRIGHT-GLEMSA STAIN (February 24, 1989)
  • K890674 — ACCUSTAIN(TM) - AUTOMATED WRIGHT GIEMSA STAIN SET (February 24, 1989)
  • K860793 — CAMCO STAIN PAK (March 18, 1986)
  • K853241 — HEMATOLOGY STAIN PACK (August 19, 1985)
  • K852138 — WESCOR STAIN PACK FOR MODEL 7100 AEROSPRAY SLIDE S (June 13, 1985)
  • K842744 — WRIGHT STAIN (August 12, 1984)
  • K842745 — WRIGHT-GIEMSA QUICK STAIN (August 10, 1984)
  • K833678 — HEMATOLOGY WRIGHT'S STAIN PACK (November 25, 1983)
  • K833260 — STAIN PACK FOR AEROSPRAY SLIDE STAINER (October 28, 1983)
  • K831605 — HEMATOLOGY PAK (June 30, 1983)