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510(k) K951639

COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) by Incstar Corp. — Product Code DAE

K951639 is an FDA 510(k) premarket notification submitted by Incstar Corp. for the device "COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE)". The FDA issued a decision of Substantially Equivalent on October 13, 1995. The device falls under product code DAE (Complement C9, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 866.5240. Incstar Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 13, 1995
Date Received
April 10, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C9, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5240
Review Panel
IM
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)
  • K955362 — INCSTAR HSV I/II IGG FAST ELISA ASSAY (July 24, 1996)
  • K955361 — INCSTAR CYTOMEGALOVIRUS IGG ELISA ASSAY (July 22, 1996)

Other clearances for product code DAE

  • K150412 — Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (August 28, 2015)
  • K113349 — HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR US (July 11, 2012)
  • K992488 — TOTAL HAEMOLYTIC COMPLEMENT RID KIT (September 17, 1999)
  • K974111 — QUIDEL CH50 EQ EIA (July 29, 1998)
  • K954145 — WAKO AUTOKIT CH50 (December 18, 1995)

FDA data resources