Home / 510(k) Clearances / K972457

510(k) K972457

MONOCOL/LEX-IM TEST by Immunostics Inc., — Product Code KTN

K972457 is an FDA 510(k) premarket notification submitted by Immunostics Inc., for the device "MONOCOL/LEX-IM TEST". The FDA issued a decision of Substantially Equivalent on December 1, 1997. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Immunostics Inc., has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1997
Date Received
July 1, 1997
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 Immunostics Inc.,

  • K221817 — ALFIS Vitamin D, ALFIS-3 Analyzer (September 22, 2023)
  • K182298 — hemochroma PLUS System (November 16, 2018)
  • K163465 — hemochroma PLUS System (September 8, 2017)
  • K163225 — AFIAS iFOB with AFIAS-50 (August 8, 2017)
  • K171484 — hema-screen SPECIFIC Gold (June 14, 2017)
  • K163554 — hema-screen ER XCEL Enhanced Readability Fecal Occult Blood Test (January 17, 2017)
  • K102664 — HEMA SCREEN ER (January 28, 2011)
  • K060463 — HEMA SCREEN SPECIFIC IFOBT (June 6, 2006)
  • K041728 — HCG DETECTOR COMBI, HCG DETECTOR STIX, HCG DETECTOR CASSETTE (August 11, 2004)
  • K031490 — RUBELLACOL (July 16, 2003)

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)
  • 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)
  • K961550 — QUALITROL MONO CONTROL SERUM SET (September 24, 1996)

FDA data resources