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IDG/Sanzay 1

by IDG/SANZAY Corporation 9 variants

IDG/Sanzay 1 (C413) is an uric acid IVD (FDA Class I; FDA product code KNK, Acid, Uric, Uricase (Colorimetric)) made by IDG/SANZAY Corporation, cleared under FDA 510(k) K914158 on 21 Feb 1992 and listed in FDA GUDID since 12 Jan 2024 (UDI-DI 00850053916168), active as of 22 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 22 Oct 2026

Documents

510(k) K914158

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 22 Oct 2026.

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number00850053916168 UDI-DI Date12 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK914158 Date21 Feb 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K914158 decided 21 Feb 1992 Active
  • FDA GUDID UDI-DI 00850053916168 listed 12 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K914158
  2. Listed FDA GUDID 00850053916168

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
IDG/Sanzay
Generic name
Uric acid IVD, reagent
Model / Ref / Catalog
1, C413
Primary DI / UDI-DI
00850053916168
510(k) Number
FDA product code
KNK
GMDN term
Uric acid IVD, reagent
Device class
Class I
Regulation number
862.1775
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 100 Milliliter
Total Volume — 120 Milliliter
Total Volume — 240 Milliliter
Total Volume — 250 Milliliter
Total Volume — 480 Milliliter
Total Volume — 500 Milliliter
Total Volume — 1 Liter

Related devices

Category: Uric acid IVD, reagent

Cleared under the same submission (K914158)

and 2 more cleared under K914158

Similar devices in this category

Other devices filed under Uric acid IVD, reagent.

Other devices from IDG/SANZAY Corporation

  • IDG/Sanzay 1

    Class II

  • IDG/Sanzay 1

    Class II

  • IDG/Sanzay 1

    Class II

  • IDG/Sanzay 1

    Class II

See all devices from IDG/SANZAY Corporation →

Properties

  • Over-the-counter
  • Lot / batch number
  • Expiration date
Other properties (12, all answered No)