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510(k) K131508

VYSIS D7S486/CEP 7 FISH PROBE KIT by Abbott Molecular, Inc. — Product Code PFG

K131508 is an FDA 510(k) premarket notification submitted by Abbott Molecular, Inc. for the device "VYSIS D7S486/CEP 7 FISH PROBE KIT". The FDA issued a decision of Substantially Equivalent on September 13, 2013. The device falls under product code PFG (Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders), a Class II device regulated under 21 CFR 864.1870. Abbott Molecular, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2013
Date Received
May 24, 2013
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
Device Class
Class II
Regulation Number
864.1870
Review Panel
PA
Submission Type

DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens.

Other clearances by Abbott Molecular, Inc.

  • K252102 — Alinity m HCV (September 25, 2025)
  • K243489 — Alinity m EBV (09N43-095) (July 28, 2025)
  • K243485 — Alinity m CMV (July 1, 2025)
  • K241921 — Alinity m BKV (March 24, 2025)
  • K241573 — Alinity m Resp-4-Plex (February 14, 2025)
  • K243410 — simpli-COLLECT STI Test (January 30, 2025)
  • K241580 — Alinity m SARS-CoV-2 AMP Kit (09N78-096); Alinity m SARS-CoV-2 CTRL Kit (09N78-0 (December 6, 2024)
  • K233349 — Alinity m HSV 1 & 2 / VZV (May 3, 2024)
  • K222379 — Alinity m STI Assay (March 3, 2023)
  • K212778 — Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N (July 15, 2022)

FDA data resources