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Collagen Reagent 5368

by Helena Laboratories, Corp.

Collagen Reagent 5368 is a Class II device made by Helena Laboratories, Corp., cleared under FDA 510(k) K910706 on 20 May 1991 and listed in FDA GUDID since 7 Sep 2016 (UDI-DI M52553680), active as of 23 Oct 2026. 2 FDA recalls are linked to it.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

510(k) K910706

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 NumberM52553680 UDI-DI Date7 Sep 2016ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK910706 Date20 May 1991DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K910706 decided 20 May 1991 Active
  • FDA GUDID UDI-DI M52553680 listed 7 Sep 2016 Listed

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-0537-2020 FDA Class III initiated 23 May 2018

    Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet aggregation Kit, may contain particulate matter or microbial growth.

    • Ongoing Z-0536-2020 FDA Class III initiated 23 May 2018

    Through an investigation, it has been determined that vials of Collagen packaged within the Collagen Reagent and Platelet Aggregation Kit may contain particulate matter or microbial growth.

Timeline

4 dated events

  1. Cleared FDA 510(k) K910706
  2. Listed FDA GUDID M52553680
  3. Recall initiated FDA recalls Z-0537-2020
  4. Recall initiated FDA recalls Z-0536-2020

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Collagen Reagent
Generic name
Platelet aggregation study IVD, reagent
Model / reference
5368
Primary DI / UDI-DI
M52553680
510(k) Number
FDA product code
GHR
GMDN term
Platelet aggregation study IVD, reagent
Device class
Class II
Regulation number
864.5700
GUDID distribution status
In Commercial Distribution

Related devices

Category: Platelet aggregation study IVD, reagent

Similar devices in this category

Other devices filed under Platelet aggregation study IVD, reagent.

Other devices from Helena Laboratories, Corp.

See all devices from Helena Laboratories, Corp. →

Properties

  • Single use
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (11, all answered No)