Home / 510(k) Clearances / K771583

510(k) K771583

FLUORESCENT ANTI. ANTI-HUMAN C3 by Burroughs Wellcome Co. — Product Code DAC

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 2, 1977
Date Received
August 18, 1977
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Complement C3b Activator, Antigen, Antiserum, Control
Device Class
Class II
Regulation Number
866.5260
Review Panel
IM
Submission Type

Other clearances by Burroughs Wellcome Co.

  • K820069 — WELLCOGEN GROUP B (February 18, 1982)
  • K813508 — SAC-CEL (December 29, 1981)
  • K810215 — DAC-CEL HCG (April 17, 1981)
  • K810214 — DAC-CEL DIAGNATAL (March 6, 1981)
  • K810212 — DAC-CEL T3 UPTAKE (February 10, 1981)
  • K810213 — DAC-CEL TSH (February 10, 1981)
  • K791232 — DAC-CEL T3 (September 4, 1979)
  • K791231 — DAC-CEL T4 (September 4, 1979)
  • K781607 — STREP-TEX (October 17, 1978)
  • K780873 — THYMUNE-M (June 14, 1978)

Other clearances for product code DAC

  • K891904 — EZ COMPLEMENT C1 (April 14, 1989)