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510(k) K853105

IMMUNO-IM by Immunostics Co., Inc. — Product Code KTN

K853105 is an FDA 510(k) premarket notification submitted by Immunostics Co., Inc. for the device "IMMUNO-IM". The FDA issued a decision of Substantially Equivalent on September 3, 1985. The device falls under product code KTN (System, Test, Infectious Mononucleosis), a Class II device regulated under 21 CFR 866.5640. Immunostics Co., Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 3, 1985
Date Received
July 23, 1985
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 Co., Inc.

  • K926569 — IMMUNO RA UNDILUTED (April 6, 1993)
  • K902360 — HEMA-SCREEN (July 27, 1990)
  • K894780 — IMMUNO/ASO (October 16, 1989)
  • K883685 — IMMUNO/FEBRILE ANTIGENS (September 28, 1988)
  • K872910 — IMMUNO/SLE (August 12, 1987)
  • K863741 — IMMUNO-CEPT D (BETA-MONOCLONAL) (November 13, 1986)
  • K854619 — DETECTACULT (March 3, 1986)
  • K842110 — SLIDE PREGNANCY TEST (July 12, 1984)
  • K834391 — IMMUNO-RA (February 3, 1984)
  • K834390 — IMMUNO-CRP (February 3, 1984)

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