510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K103112Substantially Equivalent

Affymetrix Gene Profiling Reagents

Affymetrix Inc, Redwood Shores CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K103112 is the FDA 510(k) clearance record for AFFYMETRIX GENE PROFILING REAGENTS, a class II device, cleared for Affymetrix, Inc. on under FDA product code OVA (Complete Gene Expression Profiling Accessory Reagents). FDA's definition for product code OVA reads: "Complete gene expression profiling accessory reagent kits include all components necessary to perform transcript synthesis, fluorescent labeling, and detection and are intended to carry out all processing steps for separately cleared gene...". FDA records list 4 510(k) clearances for Affymetrix, Inc., from to . As of , FDA records show no recalls naming K103112.

Clearance record

Decision date
Received
(195 days to decision)
Product code
OVA Complete Gene Expression Profiling Accessory Reagents
Regulation
21 CFR 862.2570
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Affymetrix, Inc. 3 Lagoon Dr., Redwood Shores CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OVA

Trailing 12 months

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

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