510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K131508Substantially Equivalent

Vysis D7s486/cep 7 Fish Probe Kit

Abbott Molecular, Inc., Des Plaines IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K131508 is the FDA 510(k) clearance record for VYSIS D7S486/CEP 7 FISH PROBE KIT, a class II device, cleared for Abbott Molecular, Inc. on under FDA product code PFG (Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders). FDA's definition for product code PFG reads: "DNA FISH probe kits for specimen characterization detect DNA probe targets on human chromosomes in bone marrow and peripheral blood specimens". FDA records list 19 510(k) clearances for Abbott Molecular, Inc., from to . As of , FDA records show no recalls naming K131508.

Clearance record

Decision date
Received
(112 days to decision)
Product code
PFG Dna Fish Probe Kit For Specimen Characterization, Human Chromosome, Hematological Disorders
Regulation
21 CFR 864.1870
Device class
Class II
Review panel
Hematology
Applicant
Abbott Molecular, Inc. 1300 E Touhy Ave., Des Plaines IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code PFG

Trailing 12 months

FDA records hold no clearances under product code PFG in the trailing twelve months.

FDA records show no clearances under product code PFG in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PFG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260