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510(k) K820647

GAMMA FETAL BLEED SCREENING TEST by Gamma Biologicals, Inc. — Product Code LIM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 12, 1982
Date Received
March 9, 1982
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Test, Screening, For D Positive Fetal Rbc'S
Device Class
Class II
Regulation Number
864.7455
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)
  • 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)
  • K802534 — GAMMA PI 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 LIM

  • K980314 — FETAL D TECTION KIT (April 8, 1998)