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510(k) K960367

INCSTAR RUBELLA IGG ELISA ASSAY by Incstar Corp. — Product Code LFX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 24, 1996
Date Received
January 25, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Rubella
Device Class
Class II
Regulation Number
866.3510
Review Panel
MI
Submission Type

Other clearances by Incstar Corp.

  • K963289 — INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY (May 1, 1997)
  • K963296 — INCSTAR TOXOPLASMA IGG ALISA ASSAY (CAT.#7565) (December 16, 1996)
  • K963297 — INCSTAR TOXOPLASMA IGG FAST ELISA ASSAY (CAT.#7560) (December 16, 1996)
  • K960358 — INCSTAR RUBELLA IGG FAST ELISA ASSAY (October 24, 1996)
  • K960434 — INCSTAR CYTOMEGALOVIRUS IGM CAPTURE ELISA ASSAY MODEL 8530 (October 17, 1996)
  • K953567 — INCSTAR 25-HYDROXYVITMIN D 1251 RIA (September 25, 1996)
  • K955362 — INCSTAR HSV I/II IGG FAST ELISA ASSAY (July 24, 1996)
  • K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY (July 24, 1996)
  • K955360 — INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY (July 22, 1996)
  • K955361 — INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY (July 22, 1996)

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  • K092322 — ELECSYS RUBELLA IGM IMMUNOASSAY (March 12, 2010)
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  • K072617 — ELECSYS RUBELLA IGG IMMUNOASSAY (December 5, 2008)
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  • K063186 — ATHENA MULTI-LYTE RUBELLA IGG TEST SYSTEM (March 21, 2007)