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510(k) K955362

INCSTAR HSV I/II IGG FAST ELISA ASSAY by Incstar Corp. — Product Code IGC

K955362 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "INCSTAR HSV I/II IGG FAST ELISA ASSAY". The FDA issued a decision of Substantially Equivalent on July 24, 1996. The device falls under product code IGC (Formalin-Saline), a Class I device regulated under 21 CFR 864.4010. Incstar Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 24, 1996
Date Received
November 22, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Formalin-Saline
Device Class
Class I
Regulation Number
864.4010
Review Panel
PA
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)
  • K960367 — INCSTAR RUBELLA IGG ELISA ASSAY (October 24, 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)
  • K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY (July 24, 1996)
  • K955361 — INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY (July 22, 1996)
  • K955360 — INCSTAR CYTOMEGALOVIRUS IGG FAST ELISA ASSAY (July 22, 1996)

Other clearances for product code IGC

  • K955363 — INCSTAR HSZ I/II IGG ELISA ASSAY (July 24, 1996)

FDA data resources