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510(k) K830531

MONO SCREENING TEST by Tago, Inc. — Product Code KTN

K830531 is an FDA 510(k) premarket notification submitted by Tago, Inc. for the device "MONO SCREENING TEST". The FDA issued a decision of Substantially Equivalent on March 17, 1983. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Tago, Inc. has at least 7 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 17, 1983
Date Received
February 18, 1983
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 Tago, Inc.

  • K841734 — TAGO FIFFU-GEN, OROSOMUCOID (June 1, 1984)
  • K841265 — TAGO DIFFU-GEN C-REACTIVE PROTEIN (May 22, 1984)
  • K834218 — DIFFU-GEN APOLIPOPROTEIN A-I RADIAL - (May 11, 1984)
  • K840404 — DIFFU-GEN HAPTOGLOBIN RADIAL IMMUNO (March 9, 1984)
  • K833129 — TAGO DIFFU-GEN-APOLIPOPROTEIN B-100 (November 21, 1983)
  • K830611 — RA SCREENING TEST (March 24, 1983)
  • K830156 — HCG SCREENING TEST (February 9, 1983)

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