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510(k) K954515

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

K954515 is an FDA 510(k) premarket notification submitted by Pyramid Biological Corp. for the device "ENZYME LINKED IMMUNOABSORBENT ASSAY, RUBELLA". The FDA issued a decision of Substantially Equivalent on December 20, 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 20, 1995
Date Received
September 28, 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)
  • 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)

Other clearances for product code GOM

  • K953826 — ENZYME LINKED UMMINOABSORBENT ASSAY, RUBELLA (December 14, 1995)

FDA data resources