Home / 510(k) Clearances / K882822

510(k) K882822

FIAGEN FERRITIN by Cyberfluor, Inc. — Product Code DFL

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
July 8, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Igm, Ferritin, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5550
Review Panel
IM
Submission Type

Other clearances by Cyberfluor, Inc.

  • K923410 — FIAGEN PROGESTERONE (December 3, 1992)
  • K905656 — FLAGEN TRIIODOTHYRONINE (T3) ASSAY (January 23, 1991)
  • K904539 — FLAGEN TM FREE T4 (November 30, 1990)
  • K900621 — FIAGEN(TM) HLH.S (March 1, 1990)
  • K895186 — FIAGEN T3 UPTAKE CATALOGUE #101-402 (November 8, 1989)
  • K895396 — CYBERFLUOR FIAGEN TSH (October 31, 1989)
  • K884708 — FIAGEN HFSH TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884707 — FIAGEN DIGOXIN TIME-RESOLVED FLUOROIMMUNOASSAY KIT (January 17, 1989)
  • K884201 — FIAGEN TBG TIME-RESOLVED FLUOROIMMUNOASSAY KIT (December 14, 1988)
  • K883182 — FIAGEN RUBELLA IGG (October 31, 1988)

Other clearances for product code DFL

  • K883493 — TECHNICON DPA-1 IMMUNOGLOBULIN M (September 22, 1988)
  • K772079 — RADIAL IMMUNODIFFUSION KIT-IMMUNOGLOB.M (February 3, 1978)