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510(k) K760032

TEST, MONO., DIFFERENTIAL SLIDE by Gamma Biologicals, Inc. — Product Code KIN

K760032 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "TEST, MONO., DIFFERENTIAL SLIDE". The FDA issued a decision of Substantially Equivalent on August 3, 1976. The device falls under product code KIN (Slide Stainer, Contact Type), a Class I device regulated under 21 CFR 864.3800. Gamma Biologicals, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 3, 1976
Date Received
June 14, 1976
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Slide Stainer, Contact Type
Device Class
Class I
Regulation Number
864.3800
Review Panel
PA
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)
  • K813342 — GAMMA CHLOROQUINE DIPHOSPHATE SOLUTION (March 4, 1982)
  • K820072 — FE-CULT PLUS (March 4, 1982)
  • K811752 — FE-CULT PLUS (November 2, 1981)
  • K802534 — GAMMA PI BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K802533 — GAMMA LEWIS BLOOD GROUP SUBSTANCE (November 12, 1980)
  • K800658 — RST-SERIES CONTROL (April 16, 1980)

FDA data resources