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510(k) K850786

TOTAL HIGE ENZYME IMMUNOASSAY by Nms Pharmaceuticals, Inc. — Product Code DGC

K850786 is an FDA 510(k) premarket notification submitted by Nms Pharmaceuticals, Inc. for the device "TOTAL HIGE ENZYME IMMUNOASSAY". The FDA issued a decision of Substantially Equivalent on April 12, 1985. The device falls under product code DGC (Ige, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5510. Nms Pharmaceuticals, Inc. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 12, 1985
Date Received
February 26, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Ige, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
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)
  • K850787 — SOLID PHASE FREE ESTRIOL ENZYME IMMUNOASSAY (March 26, 1985)
  • K842499 — NMS 1043 ENZYME IMMUNOASSAY KIT (September 14, 1984)

Other clearances for product code DGC

  • K231151 — Kenota 1 Total IgE; Kenota 1 (instrument) (May 31, 2024)
  • K214068 — Quantia IgE (February 21, 2023)
  • K220178 — Total Immunoglobulin E (IgE) (March 23, 2022)
  • K193493 — ADVIA Centaur Total IgE (tIgE) (January 15, 2020)
  • K161899 — ImmunoCAP Total IgE Calibrator Strip/Total IgE Curve Control Strip, ImmunoCAP To (July 28, 2016)
  • K133404 — IMMUNOCAP TOTAL IGE: CONJUGATE, ANTI-IGE, CALIBRATORS, CURVE CONTROLS, CONTROL L (February 24, 2014)
  • K063425 — DIMENSION VISTA IGE FLEX REAGENT CARTRIDGE, PROTEIN 1 CALIBRATOR, PROTEIN 1 CONT (February 15, 2007)
  • K050493 — QUANTIA IGE (August 16, 2005)
  • K042241 — K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093C (December 10, 2004)
  • K034057 — LACRYTEST (March 9, 2004)

FDA data resources