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510(k) K925183

BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST by Princeton Biomedix — Product Code KTN

K925183 is an FDA 510(k) premarket notification submitted by Princeton Biomedix for the device "BIOSIGN(TM) MONO-INFECT MONO HETERO ANTIBODY TEST". The FDA issued a decision of Substantially Equivalent on February 23, 1993. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Princeton Biomedix has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 23, 1993
Date Received
October 14, 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 Princeton Biomedix

  • K942052 — LIFESIGN MI MYOGLOBIN (February 7, 1995)
  • K925355 — BIOSIGN(TM_ RUBELLA - RUBELLA ANTIBODY TEST (July 12, 1994)
  • K930185 — OVUSIGN LH/CONCEPTION PLUS/OVUDATE LH ONE-STEP (March 4, 1993)
  • K926308 — LIFESIGN HCG - ONE STEP HOME PREGNANCY TEST (January 26, 1993)
  • K901011 — BIOSIGN HCG-ONE STEP PREGNANCY TEST (May 4, 1990)
  • K894750 — BIOSTIX I. HCG - ONE STEP PREGNANCY TEST (October 18, 1989)
  • K894705 — BIOSPOT HCG-RAPID PREGNANCY TEST (October 18, 1989)
  • K892654 — BIOSTIX (TM)HCG--SIMPLE PREGNANCY TEST (June 19, 1989)
  • K761315 — ALKALINE PHOSPHATASE (ALP)/PNPP (February 24, 1977)
  • K760346 — ASSAY FOR GAMMA GLUTAMYLTRANSFERASE (October 27, 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