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510(k) K970100

TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL by Simplicity Diagnostics, Inc. — Product Code MJX

K970100 is an FDA 510(k) premarket notification submitted by Simplicity Diagnostics, Inc. for the device "TECH SIMPLE SYPHILIS POSITIVE SERUM CONTROL MONITOR ONTRAK SYPHILIS POSITIVE SERUM CONTROL". The FDA issued a decision of Substantially Equivalent on March 10, 1997. The device falls under product code MJX (Kit, Serological, Positive Control), a Class I device regulated under 21 CFR 862.1660. Simplicity Diagnostics, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 10, 1997
Date Received
January 10, 1997
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Kit, Serological, Positive Control
Device Class
Class I
Regulation Number
862.1660
Review Panel
MI
Submission Type

Other clearances by Simplicity Diagnostics, Inc.

  • 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)
  • K922723 — TECH SIMPLE ANTISTREPTOLYSIN O ASO SERUM CONTROL (September 18, 1992)

Other clearances for product code MJX

  • K101434 — AUDIT MICROCV PROCALCITONIN LINEARITY (July 22, 2010)
  • K030067 — VITROS IMMUNODIAGNOSTIC PRODUCTS HBSAG CONTROLS (January 17, 2003)
  • K974262 — SYSCOS IDC - G, IDC, BSC, IDC - G (December 24, 1997)
  • K972986 — ACCURUN 140 RUBELLA IGG POSITIVE CONTROL (October 8, 1997)
  • K934137 — OPUS(R) SEROLOGY CONTROLS, MODIFICATION (March 7, 1994)
  • K925703 — OPUS SEROLOGY CONTROLS (April 8, 1993)

FDA data resources