Skip to content

Borrelia IgM Control BBM-6130

by Bion Enterprises, Ltd.

Borrelia IgM Control BBM-6130 is a Class II device made by Bion Enterprises, Ltd., cleared under FDA 510(k) K901054 on 5 Apr 1990 and listed in FDA GUDID since 12 Sep 2016 (UDI-DI B110BBM61300), 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) K901054

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 NumberB110BBM61300 UDI-DI Date12 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK901054 Date5 Apr 1990DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K901054 decided 5 Apr 1990 Active
  • FDA GUDID UDI-DI B110BBM61300 listed 12 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K901054
  2. Listed FDA GUDID B110BBM61300

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Borrelia IgM Control
Generic name
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control
Model / Ref / Catalog
BBM-6130
Primary DI / UDI-DI
B110BBM61300
510(k) Number
FDA product code
LSR
GMDN term
Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control
Device class
Class II
Regulation number
866.3830
GUDID distribution status
In Commercial Distribution

Related devices

Category: Borrelia burgdorferi immunoglobulin M (IgM) antibody IVD, control

Cleared under the same submission (K901054)

Other devices from Bion Enterprises, Ltd.

See all devices from Bion Enterprises, Ltd. →

Properties

  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)