Home / 510(k) Clearances / K953826

510(k) K953826

ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA by Pyramid Biological Corp. — Product Code GOM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 1995
Date Received
August 15, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antisera, Cf, Rubella
Device Class
Class II
Regulation Number
866.3510
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)
  • K961317 — SYPHILIS IGM HUMAN SERUM CONTROLS (June 24, 1996)
  • K960493 — SYPHILIS IGG HUMAN SERUM CONTROLS (June 17, 1996)
  • K954515 — ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (December 20, 1995)
  • K952818 — ENZYME LINKED IMMUNOABSORBENT ASSAY, TOXOPLASMA GONDII (November 20, 1995)
  • K951800 — CMV IGG HUMAN SERUM CONTROLS (November 16, 1995)
  • K952254 — ENZYME LINKED IMMUNOABSORBENT ASSAY, CYTOMEGALOVIRUS (November 16, 1995)
  • K944515 — SERUM PROTEIN CONTROLS (November 17, 1994)
  • K933218 — REFRACTOMETRIC, TOTAL PROTEIN (February 17, 1994)

Other clearances for product code GOM

  • K954515 — ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA (December 20, 1995)