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510(k) K953826

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

K953826 is an FDA 510(k) premarket notification submitted by Pyramid Biological Corp. for the device "ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA". The FDA issued a decision of Substantially Equivalent on December 14, 1995. The device falls under product code GOM (Antisera, Cf, Rubella), a Class II device regulated under 21 CFR 866.3510. Pyramid Biological Corp. has at least 10 other 510(k) clearances on record.

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)
  • 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)

Other clearances for product code GOM

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

FDA data resources