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510(k) K802508

RUBELISA IGM TEST KIT by M.A. Bioproducts — Product Code GOL

K802508 is an FDA 510(k) premarket notification submitted by M.A. Bioproducts for the device "RUBELISA IGM TEST KIT". The FDA issued a decision of Substantially Equivalent on December 18, 1980. The device falls under product code GOL (Antigen, Ha (Including Ha Control), Rubella), a Class II device regulated under 21 CFR 866.3510. M.A. Bioproducts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 18, 1980
Date Received
October 15, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Ha (Including Ha Control), Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

Other clearances by M.A. Bioproducts

  • K822883 — HERPELISA KIT (July 26, 1983)
  • K823804 — MYCOPLASMELISA TEST KIT (May 25, 1983)
  • K830045 — MUMPSELISA TEST KIT (May 13, 1983)
  • K830615 — CYTOMEGELISA STAT (May 9, 1983)
  • K823805 — VARICELISA TEST KIT (May 5, 1983)
  • K821967 — CHLAMYDELISA TEST KIT (August 3, 1982)
  • K821762 — MEASELISA TEST KIT (July 30, 1982)
  • K813221 — TOXOELISA TEST KIT (January 26, 1982)
  • K812531 — CELL CULTURE REAGENTS (October 23, 1981)
  • K812123 — CYTOMEGELISA TEST KIT (September 23, 1981)

Other clearances for product code GOL

  • K841174 — RUBELLA ANTIBODY FLUOROIMMUNOASSAY (June 7, 1984)
  • K834032 — RUBAQUICK DIAGNOSTIC KIT (April 17, 1984)
  • K810309 — RUBELLA ANTIBODIES TEST REAGENTS (March 11, 1981)
  • K802339 — EIA RUBELLA-G (December 18, 1980)
  • K802102 — RUBELLA ELISA REAGENTS RUBELLA IGG ANTI (December 18, 1980)
  • K801667 — GAMMA COAT(125 I) RUBELLA ANTIBODY (October 23, 1980)
  • K801098 — ENZYME-IMMUNOASSAY (RUBELLA ANTIBODIES) (September 16, 1980)
  • K801507 — ANTIGEN CONTROL CELLS (August 20, 1980)
  • K800789 — RUBELLA BIO-BEAD TITRATION KIT (June 30, 1980)
  • K800797 — MACRO-VUE RUBELLA CARD TEST (June 20, 1980)

FDA data resources