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510(k) K871395

DUAL SUBSTRATE ANA by Val Tech Diagnostics, Inc. — Product Code DHN

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 20, 1987
Date Received
April 7, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Antinuclear Antibody, Indirect Immunofluorescent, Antigen, Control
Device Class
Class II
Regulation Number
866.5100
Review Panel
IM
Submission Type

Other clearances by Val Tech Diagnostics, Inc.

  • K883569 — HISTO-CHECK GRAM NEGATIVE SLIDES (October 6, 1988)
  • K883568 — HISTO-CHECK ACID FAST SLIDES (October 6, 1988)
  • K883571 — HISTO-CHECK PARASITIC CONTROL SLIDES (October 6, 1988)
  • K883567 — HISTO-CHECK LEGIONELLA CONTROL SLIDES (October 6, 1988)
  • K883570 — HISTO-CHECK FUNGAL CONTROL SLIDES (October 6, 1988)
  • K883684 — HERPES VIRUS CONTROL SLIDES (September 28, 1988)
  • K883232 — HISTONE REACTIVE ANA (September 7, 1988)
  • K883208 — HISTO-CHECK SLIDES (August 25, 1988)
  • K864668 — ANA TEST KIT (March 12, 1987)
  • K870732 — RAT LIVER NUCLEI TEST SYSTEM (March 10, 1987)

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  • K141827 — EUROIMMUN IFA 40: HEP-20-10; EUROPATTERN MICROSCOPE AND SOFTWARE (April 17, 2015)
  • K150155 — NOVA Lite DAPI ANA Kit (April 8, 2015)
  • K131791 — IFA 40: HEP-20-10 (February 26, 2014)
  • K120889 — AESKUSLIDES ANA HEP-2 (October 15, 2012)
  • K070763 — EUROIMMUN ANA IFA: HEP-20-10 (May 22, 2007)
  • K042680 — RHIGENE HEP-ANA TEST SYSTEM (November 19, 2004)