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510(k) K771838

SERUM IRON by Gamma Enterprises, Inc. — Product Code JIY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 3, 1977
Date Received
September 21, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Photometric Method, Iron (Non-Heme)
Device Class
Class I
Regulation Number
862.1410
Review Panel
CH
Submission Type

Other clearances by Gamma Enterprises, Inc.

  • K790578 — GAMMA SMAC REAGENTS (May 15, 1979)
  • K780505 — SERUM GLUTAMIC-OXALOACETIC-TRANSAMINASE (May 3, 1978)
  • K780504 — CREATINE PHOSPHOKINASE (CPK) (May 3, 1978)
  • K780506 — CARBON DIOXIDE REAGENTS (May 3, 1978)
  • K780507 — SERUM GLUTAMIC-PYRUVIC TRANSAMINASE (May 3, 1978)
  • K771836 — LACTATE DEHYDROGENASE (November 22, 1977)
  • K771843 — WETTING AGENTS (November 22, 1977)
  • K771832 — CHLORIDE (November 22, 1977)
  • K771834 — CREATININE (November 3, 1977)
  • K771837 — POTASSIUM (November 2, 1977)

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  • K051115 — SENTINEL IRON LIQUID (August 25, 2005)
  • K033983 — VITALAB IRON REAGENT (May 21, 2004)
  • K030528 — ATAC IRON REAGENT, ATAC TIBC COLUMN KIT AND IRON CALIBRATOR (500 UG/DL) (June 17, 2003)
  • K020816 — IRON-PC-SL ASSAY MODEL # 151-10, 151-26 (May 14, 2002)
  • K013097 — WIENER LAB.FER-COLOR AA, MODEL 5X 20 ML CAT.N 1492003 (November 13, 2001)
  • K981241 — IRON (May 1, 1998)
  • K973933 — SERUM IRON-SL ASSAY, CATALOGUE NUMBERS 157-10, 157-30 (November 4, 1997)
  • K972363 — IL TEST IRON (August 15, 1997)