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510(k) K961317

SYPHILIS IGM HUMAN SERUM CONTROLS by Pyramid Biological Corp. — Product Code LIP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1996
Date Received
April 5, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
Device Class
Class II
Regulation Number
866.3830
Review Panel
MI
Submission Type

Other clearances by Pyramid Biological Corp.

  • K964675 — H.PYLORI CONTROLS (January 27, 1997)
  • K962399 — HEPATITIS NEGATIVE CONTROL (August 2, 1996)
  • K960493 — SYPHILIS IGG HUMAN SERUM CONTROLS (June 17, 1996)
  • K954515 — ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (December 20, 1995)
  • K953826 — ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA (December 14, 1995)
  • K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (November 20, 1995)
  • K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (November 16, 1995)
  • K951800 — CMV IGG HUMAN SERUM CONTROLS (November 16, 1995)
  • K944515 — SERUM PROTEIN CONTROLS (November 17, 1994)
  • K933218 — REFRACTOMETRIC, TOTAL PROTEIN (February 17, 1994)

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