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510(k) K854991

REUMAGEN ASL by Biokit USA, Inc. — Product Code GTQ

K854991 is an FDA 510(k) premarket notification submitted by Biokit USA, Inc. for the device "REUMAGEN ASL". The FDA issued a decision of Substantially Equivalent on April 18, 1986. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Biokit USA, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1986
Date Received
December 12, 1985
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 Biokit USA, Inc.

  • K913467 — TOXOGEN (January 11, 1993)
  • K910541 — BIOKIT RPR (October 18, 1991)
  • K904310 — RHEUMAGEN RF T-CONTROL (May 31, 1991)
  • K910539 — RHEUMAJET RF (April 5, 1991)
  • K910686 — RHEUMAJET CRP (March 19, 1991)
  • K904311 — RHEUMAGEN ASO T-CONTROL (January 25, 1991)
  • K904312 — RHEUMAGEN CRP T-CONTROL (October 1, 1990)
  • K896433 — MODIFIED RUBAGEN (November 29, 1989)
  • K896272 — QUANTEX CRP PLUS (LATEX, BUFFER, STANDARD, CONTROL (November 8, 1989)
  • K896271 — QUANTEX RF PLUS (LATEX, BUFFER STANDARD, CONTROL) (November 8, 1989)

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