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510(k) K781895

BLOOD GROUP SUBSTANCE B by North American Biologicals, Inc. — Product Code KSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 20, 1978
Date Received
November 6, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Substance, Blood Grouping Of Non-Human Origin For In Vitro Diagnostic Use
Device Class
Class II
Regulation Number
864.9160
Review Panel
HE
Submission Type

Other clearances by North American Biologicals, Inc.

  • K820301 — PLASMA POOLER HEAT SEALER (April 9, 1982)
  • K801219 — PLASMAPOOLER (October 31, 1980)
  • K801425 — RH CONTROL (July 14, 1980)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)

Other clearances for product code KSX

  • K802534 — GAMMA PI BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K800916 — P1 BLOOD GROUP SUBSTANCE (May 8, 1980)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)
  • K771488 — P1 BLOOD GROUP SUBSTANCE (November 8, 1977)
  • K771487 — LEWIS BLOOD GROUP SUBSTANCE (November 8, 1977)