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Savanna M409-1

by Diagnostic Hybrids, Inc.

Savanna M409-1 is a Class II device made by Diagnostic Hybrids, Inc., cleared under FDA 510(k) K232286 on 20 Dec 2023 and listed in FDA GUDID since 30 Apr 2024 (UDI-DI 30014613340485), active as of 23 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

510(k) K232286

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number30014613340485 UDI-DI Date30 Apr 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK232286 Date20 Dec 2023DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K232286 decided 20 Dec 2023 Active
  • FDA GUDID UDI-DI 30014613340485 listed 30 Apr 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K232286
  2. Listed FDA GUDID 30014613340485

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Savanna
Generic name
Multiple-type sexually transmitted pathogen nucleic acid IVD, control
Model / Ref / Catalog
M409-1
Primary DI / UDI-DI
30014613340485
510(k) Number
FDA product code
PMN
GMDN term
Multiple-type sexually transmitted pathogen nucleic acid IVD, control
Device class
Class II
Regulation number
866.3920
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple-type sexually transmitted pathogen nucleic acid IVD, control

Cleared under the same submission (K232286)

Similar devices

Other devices filed under FDA product code PMN (Assayed external control material for microbiology nucleic acid amplification (NAT) assays).

Other devices from Diagnostic Hybrids, Inc.

See all devices from Diagnostic Hybrids, Inc. →

Properties

  • Single use
  • Prescription use
  • Convenience kit
  • Lot / batch number
  • Expiration date
  • Manufacturing date
Other properties (9, all answered No)