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RealTime 8L07-67

by Abbott Molecular

RealTime 8L07-67 is a Class I device made by Abbott Molecular, cleared under FDA 510(k) K140354 on 9 May 2014 and listed in FDA GUDID since 1 Sep 2016 (UDI-DI 00884999037410), 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) K140354

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 Number00884999037410 UDI-DI Date1 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK140354 Date9 May 2014DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K140354 decided 9 May 2014 Active
  • FDA GUDID UDI-DI 00884999037410 listed 1 Sep 2016 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K140354
  2. Listed FDA GUDID 00884999037410

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
RealTime
Generic name
DNA anti-contamination enzyme reagent IVD
Model / Ref / Catalog
8L07-67
Primary DI / UDI-DI
00884999037410
510(k) Number
FDA product code
LIO, MKZ, LSL
GMDN term
DNA anti-contamination enzyme reagent IVD
Device class
Class I
Regulation number
866.2900, 866.3120, 866.3390
GUDID distribution status
In Commercial Distribution

Related devices

Category: DNA anti-contamination enzyme reagent IVD

Cleared under the same submission (K140354)

and 2 more cleared under K140354

Similar devices

Also classified as DNA anti-contamination enzyme reagent IVD.

Similar devices

Other devices filed under FDA product code LIO (DEVICE, SPECIMEN COLLECTION).

Other devices from Abbott Molecular

See all devices from Abbott Molecular →

Properties

  • Prescription use
  • Lot / batch number
Other properties (13, all answered No)