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510(k) K821762

MEASELISA TEST KIT by M.A. Bioproducts — Product Code LJB

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 30, 1982
Date Received
June 15, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rubeola Igg
Device Class
Class I
Regulation Number
866.3520
Review Panel
MI
Submission Type

The qualitative detection of measles specific IgG antibodies in serum or plasma.

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)
  • K813221 — TOXOELISA TEST KIT (January 26, 1982)
  • K812531 — CELL CULTURE REAGENTS (October 23, 1981)
  • K812123 — CYTOMEGELISA TEST KIT (September 23, 1981)
  • K802508 — RUBELISA IGM TEST KIT (December 18, 1980)

Other clearances for product code LJB

  • K974552 — DIAMEDIX IS-MEASLES IGG TEST SYSTEM (January 28, 1998)
  • K971620 — QUANTA LITE RUBEOLA (MEASLES) IGG (July 22, 1997)
  • K922330 — BARTELS RUBEOLA IGG EIA (September 2, 1992)
  • K922335 — BARTELS RUBEOLA IGM EIA (September 2, 1992)
  • K910290 — VIRATEST-DIA(TM) MEASLES (RUBEOLA) (March 18, 1992)
  • K904083 — RUBEOLA IGM ELISA TEST (January 3, 1991)
  • K903961 — MEASLES IGG MICROASSAY (December 28, 1990)
  • K904854 — RUBEOLA IGG ELISA TEST (December 4, 1990)
  • K891990 — RUBEOLA IGG CLIN-ELISA TEST SYSTEM, CAT. #4600 (June 15, 1989)
  • K873925 — VIRGO(TM) MEASLES IGG ELISA (February 24, 1988)