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510(k) K883004

MONO-PLUS(TM) by Wampole Laboratories — Product Code KTN

K883004 is an FDA 510(k) premarket notification submitted by Wampole Laboratories for the device "MONO-PLUS(TM)". The FDA issued a decision of Substantially Equivalent on August 4, 1988. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Wampole Laboratories has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 4, 1988
Date Received
July 18, 1988
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 Wampole Laboratories

  • K965129 — BORRELIA BURGDORFERI IGM ELISA TEST SYSTEM (March 26, 1997)
  • K965131 — BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM (March 26, 1997)
  • K911444 — RUBELLA VIRUS IMMUNOLOGICAL TEST SYSTEM (August 30, 1991)
  • K882896 — ONE-STEP HCG (October 31, 1988)
  • K875101 — VIROGEN CMV ANTIBODY TEST (March 1, 1988)
  • K875161 — MAT (TM) MICROALBUMIN TEST (February 17, 1988)
  • K791309 — UCG-LYPHOTEST (July 30, 1979)
  • K790986 — RF CONTROLS (June 28, 1979)
  • K781794 — BETA-TEC (December 29, 1978)
  • K760336 — BIOCEPT-G (November 12, 1976)

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