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510(k) K963425

GENZYME DIAGNOSTICS CONTRAST MONO by Genzyme Diagnostics — Product Code KTN

K963425 is an FDA 510(k) premarket notification submitted by Genzyme Diagnostics for the device "GENZYME DIAGNOSTICS CONTRAST MONO". The FDA issued a decision of Substantially Equivalent on February 25, 1997. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Genzyme Diagnostics has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 25, 1997
Date Received
August 30, 1996
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 Genzyme Diagnostics

  • K043385 — OSOM HCG COMBO TEST (April 12, 2005)
  • K983399 — GIARDIA/CRYPTOSPORIDIUM COMBO RAPID ASSAY (January 11, 1999)
  • K964155 — CONTRAST HCG URINE/SERUM TEST AND RAPID HCG URINE/SERUM TEST (November 25, 1996)
  • K964156 — CONTRAST STRIP HCG (November 25, 1996)

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)
  • 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