Amplifine

by Bimini Technologies LLC

Amplifine is a Class II device made by Bimini Technologies LLC, listed under FDA premarket submission BK200449 and listed in FDA GUDID since 9 Feb 2022 (UDI-DI 00850034511290), active as of 21 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 21 Oct 2026

Documents

510(k) BK200449

FDA submission, from GUDID

Trust

Source GUDID, synced 21 Oct 2026.

Regulatory status

as of registry sync 21 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00850034511290 UDI-DI	Date9 Feb 2022Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k) from GUDID	NumberBK200449	Date—	StatusActive

Official records

AccessGUDID record UDI-DI 00850034511290

Across registries

2 registries list this device

FDA premarket submission BK200449 Active
FDA GUDID UDI-DI 00850034511290 listed 9 Feb 2022 Listed

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Generic name: Haematological concentrate system preparation kit, platelet concentration
Model / reference: AMPLIFINE

Primary DI / UDI-DI: 00850034511290
FDA product code: ORG
GMDN term: Haematological concentrate system preparation kit, platelet concentration

Device class: Class II
Regulation number: 864.9245
GUDID distribution status: In Commercial Distribution

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Properties

Supplied sterile
Single use
Prescription use
Lot / batch number
Expiration date

Other properties (10, all answered No)