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PlasmaCon LA 150-200

by r2 Diagnostics Inc.

PlasmaCon LA 150-200 is a Class II device made by r2 Diagnostics Inc., cleared under FDA 510(k) K083878 on 25 Jun 2010 and listed in FDA GUDID since 15 Nov 2016 (UDI-DI 10859394006122), 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) K083878

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 Number10859394006122 UDI-DI Date15 Nov 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK083878 Date25 Jun 2010DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K083878 decided 25 Jun 2010 Active
  • FDA GUDID UDI-DI 10859394006122 listed 15 Nov 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K083878
  2. Listed FDA GUDID 10859394006122

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
PlasmaCon LA
Generic name
Multiple coagulation marker IVD, control
Model / Ref / Catalog
150-200
Primary DI / UDI-DI
10859394006122
510(k) Number
FDA product code
GGC, GIR
GMDN term
Multiple coagulation marker IVD, control
Device class
Class II
Regulation number
864.5425, 864.8950
GUDID distribution status
In Commercial Distribution

Related devices

Category: Multiple coagulation factor IVD, control

Cleared under the same submission (K083878)

Similar devices in this category

Other devices filed under Multiple coagulation factor IVD, control.

Other devices from r2 Diagnostics Inc.

See all devices from r2 Diagnostics Inc. →

Properties

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