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HemosIL RecombiPlasTin 2G

by Instrumentation Laboratory CO

510(k) K070005

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Source FDA 510(k), synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK070005 Date15 Aug 2007ClearedStatusActive

Official records

Recalls

1 recall · FDA

    • Terminated Z-1784-2013 FDA Class II initiated 9 Apr 2013

    Instrumentation Laboratory is recalling HemosIL RecombiPlasTin 2G (RPT2G), Part No. 0020009580 (8 mL Size) due to being Out of Specification.

Timeline

2 dated events

  1. Cleared FDA 510(k) K070005
  2. Recall initiated FDA recalls Z-1784-2013

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  • Withdrawn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
GJS
Device class
Class II
Regulation
21 CFR Part 864.7750
Advisory committee
Hematology
FDA decision
SESE Substantially Equivalent

Overview

AI-generated summary, 6 Oct 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

HemosIL RecombiPlasTin 2G is a prothrombin time test reagent used to measure the time required for the conversion of fibrinogen to fibrin. By adding tissue thromboplastin to patient plasma in the presence of calcium ions, the reagent initiates the activation of the extrinsic coagulation pathway.

This device is regulated under 21 CFR 864.7750 and has received FDA 510(k) clearance. The reagent is formulated to be insensitive to therapeutic levels of heparin.

Devices cleared under K070005

1 device · 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 K070005
UDI-DISize and differences
HemosIL RecombiPlasTin 2G (20 mL) 00020003050
INSTRUMENTATION LABORATORY COMPANY
00020003050 / 0002000305008426950447627 —On the market

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