510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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DEN130010Unknown

Vysis Egr1 Fish Probe Kit - Sc (Specimen Characterization)

Abbott Molecular, Inc., Des Plaines IL / Post-NSE, Unknown
FDA source (opens on fda.gov)

DEN130010 is the FDA 510(k) clearance record for VYSIS EGR1 FISH PROBE KIT - SC (SPECIMEN CHARACTERIZATION), a class II device, cleared for Abbott Molecular, Inc. on under FDA product code PDO (Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization). FDA's definition for product code PDO reads: "The EGR1 FISH Probe Kit for specimen characterization detects the LSI EGR1 probe target on chromosome 5q in bone marrow specimens. This assay is used to characterize bone marrow specimens from patients with acute myeloid leukemia (AML) or...". FDA records list 19 510(k) clearances for Abbott Molecular, Inc., from to . As of , FDA records show no recalls naming DEN130010.

Clearance record

Decision date
Received
(111 days to decision)
Product code
PDO Early Growth Response Gene 1 (Egr1) Fish Probe Kit For Specimen Characterization
Regulation
21 CFR 864.1870
Device class
Class II
Review panel
Hematology
Applicant
Abbott Molecular, Inc. 1300 E Touhy Ave., Des Plaines IL
Third party review
No

Clearances, product code PDO

Trailing 12 months

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

FDA records show no clearances under product code PDO in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code PDO, 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