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510(k) K780012

ANTITHROMBIN III RIA by Ria Diagnostics — Product Code DDQ

K780012 is an FDA 510(k) premarket notification submitted by Ria Diagnostics for the device "ANTITHROMBIN III RIA". The FDA issued a decision of Substantially Equivalent on January 20, 1978. The device falls under product code DDQ (Antigen, Antiserum, Control, Antithrombin Iii), a Class II device regulated under 21 CFR 864.7060. Ria Diagnostics has at least 6 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 20, 1978
Date Received
January 3, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antigen, Antiserum, Control, Antithrombin Iii
Device Class
Class II
Regulation Number
864.7060
Review Panel
HE
Submission Type

Other clearances by Ria Diagnostics

  • K855033 — T-3 UPTAKE/RIASSAY (January 24, 1986)
  • K854798 — T-4 RIASSAY (January 15, 1986)
  • K852537 — T-3 RIASSAY (August 12, 1985)
  • K810296 — DIGOXIN RIA ASSAY (February 19, 1981)
  • K801691 — TSH RIASSAY (August 27, 1980)
  • K792062 — THEOPHYLLINE RIASSAY (February 25, 1980)

Other clearances for product code DDQ

  • K972257 — N-ASSAY TIA ANTITHROMBIN III TEST KIT (October 20, 1997)
  • K935307 — DADE(R) THROMBIN-ANTITHROMBIN (TAT) COMPLEX ELISA (November 22, 1994)
  • K932713 — TRACE TRANSFERRIN REAGENT (September 30, 1993)

FDA data resources