Home / 510(k) Clearances / K924892

510(k) K924892

FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM by Organon Teknika Corp. — Product Code DAT

K924892 is an FDA 510(k) premarket notification submitted by Organon Teknika Corp. for the device "FIBRINOSTIKA(R) FGDP MICROELISA SYSTEM". The FDA issued a decision of Substantially Equivalent on April 21, 1994. The device falls under product code DAT (Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control), a Class II device regulated under 21 CFR 864.7340. Organon Teknika Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 21, 1994
Date Received
September 29, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Fibrinogen And Split Products, Peroxidase, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
864.7340
Review Panel
HE
Submission Type

Other clearances by Organon Teknika Corp.

  • K003104 — BACT/ALERT CSR (October 20, 2000)
  • K000492 — MDA D-DIMER (June 7, 2000)
  • K000378 — BACT/ALERT MB CULTURE BOTTLE (March 2, 2000)
  • K994343 — BACT/ALERT SV (February 10, 2000)
  • K993423 — BACT/ALERT SA (December 15, 1999)
  • K993421 — BACT/ALERT SN (December 14, 1999)
  • K993576 — BACT/ALERT MP PROCESS BOTTLE (December 14, 1999)
  • K992432 — BACT/ALERT FN (September 24, 1999)
  • K983762 — NUCLISENS CMV PP67 (September 15, 1999)
  • K992401 — BACT/ALERT PF (September 3, 1999)

Other clearances for product code DAT

  • K781103 — SPECTRASCAN (September 27, 1978)

FDA data resources