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510(k) K813508

SAC-CEL by Burroughs Wellcome Co. — Product Code KTS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1981
Date Received
December 15, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Second Antibody (Species Specific Anti-Animal Gamma Globulin)
Device Class
Class II
Regulation Number
866.5510
Review Panel
IM
Submission Type

Other clearances by Burroughs Wellcome Co.

  • K820069 — WELLCOGEN GROUP B (February 18, 1982)
  • 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)
  • K780874 — THYMUNE-T (June 14, 1978)

Other clearances for product code KTS

  • K792637 — CENTRIA-SET TYPE D(ANTI-SHEEP/GOAT) (January 11, 1980)
  • K792636 — CENTRIA RADIOIMMUNOASSAY SEPARATION (January 11, 1980)
  • K781070 — SECOND ANTIBODY (August 10, 1978)