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510(k) K922726

TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL by Simplicity Diagnostics, Inc. — Product Code KTN

K922726 is an FDA 510(k) premarket notification submitted by Simplicity Diagnostics, Inc. for the device "TECH SIMPLE INFECTIOUS MONONUCLEOSIS SERUM CONTROL". The FDA issued a decision of Substantially Equivalent on October 5, 1992. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Simplicity Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 5, 1992
Date Received
June 5, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
System, Test, Infectious Mononucleosis
Device Class
Class II
Regulation Number
866.5640
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)
  • K922722 — TECH DIMPLE C-REACTIVE PROTEIN SERUM CONTROL (October 5, 1992)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (September 18, 1992)

Other clearances for product code KTN

  • K181436 — OSOM Mono Test; Sure Vue Signature Mono; ImmunoCard STAT Mono; Cardinal Health M (June 22, 2018)
  • K042272 — ACON MONONUCLEOSIS RAPID TEST STRIP (WHOLE BLOOD/SERUM/PLASMA) (February 28, 2005)
  • K030215 — BIORAPID MONONUCLEOSIS (February 24, 2003)
  • K012901 — COLOR-MONOGEN (September 27, 2001)
  • K982634 — DRYSPOT INFECTIOUS MONONUCLEOSIS KIT (January 28, 1999)
  • K981946 — CLEARVIEW IM (December 10, 1998)
  • K972457 — MONOCOL/LEX-IM TEST (December 1, 1997)
  • K972231 — OSOM MONO TEST 143 (August 26, 1997)
  • K963425 — GENZYME DIAGNOSTICS CONTRAST MONO (February 25, 1997)
  • K961024 — BIOSIGN MONO-PLUS WB,BIOSIGN MONO WB,MONO-PLUS WB,ACCUSIGN MONO WB (February 4, 1997)

FDA data resources