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510(k) K922330

BARTELS RUBEOLA IGG EIA by Baxter Diagnostics, Inc. — Product Code LJB

K922330 is an FDA 510(k) premarket notification submitted by Baxter Diagnostics, Inc. for the device "BARTELS RUBEOLA IGG EIA". The FDA issued a decision of Substantially Equivalent on September 2, 1992. The device falls under product code LJB (Enzyme Linked Immunoabsorbent Assay, Rubeola Igg), a Class I device regulated under 21 CFR 866.3520. Baxter Diagnostics, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1992
Date Received
May 13, 1992
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 Baxter Diagnostics, Inc.

  • K934458 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (July 18, 1995)
  • K950817 — DRIED GRAM POSITIVE MIC/COMBO PANELS/PNEUMOCOCCI (April 25, 1995)
  • K935704 — DRIED GRAM-NEGATIVE MIC//COMBO PANELS (April 14, 1995)
  • K950570 — STRATUS PROGESTERONE FLUOROMETRIC ENZYME IMMUNOASSAY (April 11, 1995)
  • K945235 — DRIED GRAM-POSITIVE MIC/COMBO PANELS (March 7, 1995)
  • K941030 — DRIED GRAM-NEGATIVE CEFPODOXIME (February 16, 1995)
  • K940917 — LORACARBEF GRAM-NAGATIVE PANELS (February 8, 1995)
  • K941459 — GRAM POSITIVE DRIED OVERNIGHT PANELS/LOMEFLOX (February 3, 1995)
  • K941317 — DRIED GRAM NEGATIVE/CEFMETAZOLE (January 31, 1995)
  • K942089 — MICRODILUTION/LORACARBEF PANELS (January 9, 1995)

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)
  • 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