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510(k) K873925

VIRGO(TM) MEASLES IGG ELISA by Electro-Nucleonics Laboratories, Inc. — Product Code LJB

K873925 is an FDA 510(k) premarket notification submitted by Electro-Nucleonics Laboratories, Inc. for the device "VIRGO(TM) MEASLES IGG ELISA". The FDA issued a decision of Substantially Equivalent on February 24, 1988. The device falls under product code LJB (Enzyme Linked Immunoabsorbent Assay, Rubeola Igg), a Class I device regulated under 21 CFR 866.3520. Electro-Nucleonics Laboratories, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 1988
Date Received
September 25, 1987
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 Electro-Nucleonics Laboratories, Inc.

  • K873617 — GEMSTAR II SYSTEM (October 19, 1987)
  • K873416 — MULTI-ACCESS REAGENT DISPENSER (October 9, 1987)
  • K873358 — GEMENI URIC ACID U.V. (September 11, 1987)
  • K873088 — VIRGO(TM) RUBELLA IGG ELISA (September 9, 1987)
  • K871905 — TOXOPLASMA GONDII IGG ELISA (July 30, 1987)
  • K870928 — CHOLESTEROL (TOTAL) ANALYSIS PRODUCTS (April 22, 1987)
  • K863874 — LIPASE HYDROLYSIS/GLYCEROL KINASE, TRIGLYCERIDES (November 13, 1986)
  • K862640 — AMYLASE LTS (September 9, 1986)
  • K853372 — GEMSTAR IPA THEOPHYLLINE TEST KIT (September 4, 1985)
  • K853373 — DELTA TROL I & II (August 23, 1985)

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)
  • 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)
  • K821762 — MEASELISA TEST KIT (July 30, 1982)

FDA data resources