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510(k) K963289

INCSTAR TOXOPLASMA IGM CAPTURE ELISA ASSAY by Incstar Corp. — Product Code LGD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 1, 1997
Date Received
August 21, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Enzyme Linked Immunoabsorbent Assay, Toxoplasma Gondii
Device Class
Class II
Regulation Number
866.3780
Review Panel
MI
Submission Type

Other clearances by Incstar Corp.

  • 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)
  • K960367 — INCSTAR RUBELLA IGG 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)
  • K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY (July 24, 1996)
  • K955362 — INCSTAR HSV I/II IGG FAST 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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  • K132234 — LIAISON(R) TOXO IGG II, LIAISON(R) CONTROL TOXO IGG II (August 28, 2013)
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  • K101946 — VIDAS TOXO IGG AVIDITY (May 18, 2011)
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