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Myoglobin Control Set 11730835216

by Roche Diagnostics GmbH

Myoglobin Control Set 11730835216 is a Class I device made by Roche Diagnostics GmbH, cleared under FDA 510(k) K973358 on 6 Oct 1997 and listed in FDA GUDID since 18 Jan 2021 (UDI-DI 04015630909032), active as of 12 Nov 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 12 Nov 2026

Documents

510(k) K973358

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 12 Nov 2026.

Regulatory status

as of registry sync 12 Nov 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number04015630909032 UDI-DI Date18 Jan 2021ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK973358 Date6 Oct 1997DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K973358 decided 6 Oct 1997 Active
  • FDA GUDID UDI-DI 04015630909032 listed 18 Jan 2021 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K973358
  2. Listed FDA GUDID 04015630909032

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Myoglobin Control Set
Generic name
Myoglobin IVD, control
Model / Ref / Catalog
11730835216
Primary DI / UDI-DI
04015630909032
510(k) Number
FDA product code
JJX
GMDN term
Myoglobin IVD, control
Device class
Class I
Regulation number
862.1660
GUDID distribution status
In Commercial Distribution

Related devices

Category: Myoglobin IVD, control

Other devices from Roche Diagnostics GmbH

See all devices from Roche Diagnostics GmbH →

Properties

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