510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K132200Substantially Equivalent

Pro Hmpv+ Assay

Gen-Probe Prodesse, Inc., Waukesha WI / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K132200 is the FDA 510(k) clearance record for PRO HMPV+ ASSAY, a class II device, cleared for Gen-Probe Prodesse, Inc. on under FDA product code OEM (Human Metapneumovirus (Hmpv) Rna Assay System). FDA's definition for product code OEM reads: "A qualitative in vitro diagnostic assay intended to detect human metapneumovirus (hmpv) rna extracted from human respiratory specimens or viral cultures. Detection of hmpv rna aids in the diagnosis of respiratory hmpv infection in...". FDA records list 10 510(k) clearances for Gen-Probe Prodesse, Inc., from to . As of , FDA records show no recalls naming K132200.

Clearance record

Decision date
Received
(29 days to decision)
Product code
OEM Human Metapneumovirus (Hmpv) Rna Assay System
Regulation
21 CFR 866.3980
Device class
Class II
Review panel
Microbiology
Applicant
Gen-Probe Prodesse, Inc. 20925 Crossroads Cir., Waukesha WI
510(k) summary
Summary PDF
Third party review
No

Clearances, product code OEM

Trailing 12 months

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

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