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510(k) K802534

GAMMA PI BLOOD GROUP SUBSTANCE by Gamma Biologicals, Inc. — Product Code KSX

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 12, 1980
Date Received
October 15, 1980
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 Gamma Biologicals, Inc.

  • K864207 — DISPOSABLE TEST CARDS/GAMMA SLIDE TEST INFECT MONO (December 3, 1986)
  • K861016 — GAMMA SLIDE TEST FOR INFECTIOUS MONONUCLEOSIS (April 18, 1986)
  • K832473 — GAMMA SLIDE TEST FOR PREGNANCY (August 16, 1983)
  • K820647 — GAMMA FETAL BLEED SCREENING TEST (May 12, 1982)
  • K820072 — FE-CULT PLUS (March 4, 1982)
  • K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (March 4, 1982)
  • K811752 — FE-CULT PLUS (November 2, 1981)
  • K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K800658 — RST-SERIES CONTROL (April 16, 1980)
  • K792583 — GAMMA ARACHIS HYPOGEA LECTIN (January 16, 1980)

Other clearances for product code KSX

  • K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K800916 — P1 BLOOD GROUP SUBSTANCE (May 8, 1980)
  • K781896 — BLOOD GROUP SUBSTANCE A,B (December 20, 1978)
  • K781862 — BLOOD GROUP SUBSTANCE A (December 20, 1978)
  • K781895 — BLOOD GROUP SUBSTANCE B (December 20, 1978)
  • K771487 — LEWIS BLOOD GROUP SUBSTANCE (November 8, 1977)
  • K771488 — P1 BLOOD GROUP SUBSTANCE (November 8, 1977)