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510(k) K760096

REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O by Gamma Biologicals, Inc. — Product Code GTQ

K760096 is an FDA 510(k) premarket notification submitted by Gamma Biologicals, Inc. for the device "REAGENT, LYOPHILIZED ANTI-STREPTOLYSIN O". The FDA issued a decision of Substantially Equivalent on August 3, 1976. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. 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
Antistreptolysin - Titer/Streptolysin O Reagent
Device Class
Class I
Regulation Number
866.3720
Review Panel
MI
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)

Other clearances for product code GTQ

  • K052645 — VITROS CHEMISTRY PRODUCTS CALIBRATOR KIT 28, REF 680 2323; VITROS CHEMISTRY PROD (December 14, 2005)
  • K953437 — OLYMPUS ANTI-STERPTOLYSIN O IMMUNOTURBIDIMETRIC REAGENT (October 20, 1995)
  • K915742 — TURBIQUANT ASL (June 28, 1993)
  • K926236 — BECKMAN ANTI-STREPTOLYSIN O KIT (June 15, 1993)
  • K924247 — ACCUTEX ASO LATEX TEST (December 7, 1992)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (September 18, 1992)
  • K915053 — BECKMAN ANTISTREPTOLYSIN O, MODIFICATION (March 19, 1992)
  • K912150 — BECKMAN ANTI-STREPTOLYSIN O (ASO) KIT (July 17, 1991)
  • K904416 — CROATEST (R) RHEUMATOID DIAGNOSTIC (June 24, 1991)
  • K910885 — QM300 CALIBRATOR G PACK (June 17, 1991)

FDA data resources