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510(k) K910290

VIRATEST-DIA(TM) MEASLES (RUBEOLA) by Virus Reference Laboratory, Inc. — Product Code LJB

K910290 is an FDA 510(k) premarket notification submitted by Virus Reference Laboratory, Inc. for the device "VIRATEST-DIA(TM) MEASLES (RUBEOLA)". The FDA issued a decision of Substantially Equivalent on March 18, 1992. The device falls under product code LJB (Enzyme Linked Immunoabsorbent Assay, Rubeola Igg), a Class I device regulated under 21 CFR 866.3520.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 18, 1992
Date Received
January 22, 1991
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 for product code LJB

  • K974552 — DIAMEDIX IS-MEASLES IGG TEST SYSTEM (January 28, 1998)
  • K971620 — QUANTA LITE RUBEOLA (MEASLES) IGG (July 22, 1997)
  • K922335 — BARTELS RUBEOLA IGM EIA (September 2, 1992)
  • K922330 — BARTELS RUBEOLA IGG EIA (September 2, 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)
  • K821762 — MEASELISA TEST KIT (July 30, 1982)

FDA data resources