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510(k) K922723

TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL by Simplicity Diagnostics, Inc. — Product Code GTQ

K922723 is an FDA 510(k) premarket notification submitted by Simplicity Diagnostics, Inc. for the device "TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL". The FDA issued a decision of Substantially Equivalent on September 18, 1992. The device falls under product code GTQ (Antistreptolysin - Titer/Streptolysin O Reagent), a Class I device regulated under 21 CFR 866.3720. Simplicity Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 18, 1992
Date Received
June 5, 1992
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 Simplicity Diagnostics, Inc.

  • K970100 — TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SER (March 10, 1997)
  • K922725 — TECH SIMPLE RHEUMATOID FACTOR SERUM CONTROL (October 5, 1992)
  • K922726 — TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL (October 5, 1992)
  • K922722 — TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL (October 5, 1992)

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)
  • 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)
  • K910887 — QM300 CONTROL G PACK (June 17, 1991)

FDA data resources