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510(k) K812123

CYTOMEGELISA TEST KIT by M.A. Bioproducts

K812123 is an FDA 510(k) premarket notification submitted by M.A. Bioproducts for the device "CYTOMEGELISA TEST KIT". The FDA issued a decision of Substantially Equivalent on September 23, 1981. M.A. Bioproducts has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 23, 1981
Date Received
July 27, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

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)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)

FDA data resources