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TEG5000 01-097

by Haemonetics Corporation

TEG5000 01-097 is a Class II device made by Haemonetics Corporation, cleared under FDA 510(k) K993678 on 5 May 2000 and listed in FDA GUDID since 13 Mar 2017 (UDI-DI 10812747018159), 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) K993678

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 Number10812747018159 UDI-DI Date13 Mar 2017ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK993678 Date5 May 2000DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K993678 decided 5 May 2000 Active
  • FDA GUDID UDI-DI 10812747018159 listed 13 Mar 2017 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K993678
  2. Listed FDA GUDID 10812747018159

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
TEG5000
Generic name
Coagulation analyser IVD, laboratory
Model / reference
01-097
Primary DI / UDI-DI
10812747018159
510(k) Number
FDA product code
JPA
GMDN term
Coagulation analyser IVD, laboratory
Device class
Class II
Regulation number
864.5425
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 1000 Milliliter

Related devices

Category: Coagulation analyser IVD, laboratory

Cleared under the same submission (K993678)

and 6 more cleared under K993678

Similar devices in this category

Other devices filed under Coagulation analyser IVD, laboratory.

Other devices from Haemonetics Corporation

See all devices from Haemonetics Corporation →

Properties

  • Prescription use
Other properties (14, all answered No)