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510(k) K974552

DIAMEDIX IS-MEASLES IGG TEST SYSTEM by Diamedix Corp. — Product Code LJB

K974552 is an FDA 510(k) premarket notification submitted by Diamedix Corp. for the device "DIAMEDIX IS-MEASLES IGG TEST SYSTEM". The FDA issued a decision of Substantially Equivalent on January 28, 1998. The device falls under product code LJB (Enzyme Linked Immunoabsorbent Assay, Rubeola Igg), a Class I device regulated under 21 CFR 866.3520. Diamedix Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 28, 1998
Date Received
December 4, 1997
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 Diamedix Corp.

  • K093101 — MAGO 4S (January 21, 2011)
  • K021394 — DIAMEDIX IS-RHEUMATOID FACTOR TEST SYSTEM (July 9, 2002)
  • K013956 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I SCREEN (January 8, 2002)
  • K013628 — DIAMEDIX IS-ANTI-B2 GLYCOPROTEIN I IGG/IGM TEST SYSTEM (December 21, 2001)
  • K012449 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGG/IGM TEST SYSTEM (October 26, 2001)
  • K012450 — DIAMEDIX IS-ANTI-CARDIOLIPIN IGA TEST SYSTEM (October 26, 2001)
  • K012795 — DIAMEDIX IS-ANTI-GLIADIN IGG TEST SYSTEM (September 28, 2001)
  • K012797 — DIAMEDIX IS-ANTI-GLIADIN IGA TEST SYSTEM (September 28, 2001)
  • K012053 — DIAMEDIX IS-ANTI-CARDIOLIPIN SCREEN TEST SYSTEM (August 20, 2001)
  • K002262 — DIAMEDIX IS-HSV 1&2 IGM TEST SYSTEM (November 28, 2000)

Other clearances for product code LJB

  • 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)
  • K873925 — VIRGO(TM) MEASLES IGG ELISA (February 24, 1988)
  • K821762 — MEASELISA TEST KIT (July 30, 1982)

FDA data resources