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Quantia La(a)

by Biokit, S.A.

510(k) K050487

Quantia La(a) is a Class II device made by Biokit, S.A., cleared under FDA 510(k) K050487 on 26 Apr 2005, active as of 10 Oct 2026.

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 10 Oct 2026

Documents

Trust

Unverified

Source FDA 510(k), synced 10 Oct 2026.

Regulatory status

as of registry sync 10 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK050487 Date26 Apr 2005ClearedStatusActive

Official records

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA product code
DFC
Device class
Class II
Regulation
21 CFR Part 866.5600
Advisory committee
Immunology
FDA decision
SESE Substantially Equivalent

Related clearances

Clearances this device's FDA summary refers to, and clearances whose summaries refer to it: a citation, not a claim of equivalence.

Cited by

Source: 510k-lineage (choiben314), CC BY 4.0

Devices cleared under K050487

3 devices · FDA GUDID

Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.

Devices cleared under K050487
UDI-DISize and differences
Alinity 01R1421
Abbott Laboratories
01R1421 / 01R142100380740153847 —On the market
ARCHITECT 07K0041
Abbott Laboratories
07K0041 / 07K004100380740156435 —On the market
ARCHITECT 7K00-40
Abbott Laboratories
07K0040 / 7K00-4000380740054267 —On the market

Similar devices

Other devices filed under FDA product code DFC (Lipoprotein, Low-Density, Antigen, Antiserum, Control).

Other devices from Biokit, S.A.

See all devices from Biokit, S.A. →