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IDG/Sanzay 1

by IDG/SANZAY Corporation 17 variants

IDG/Sanzay 1 (C105) is a medical device (FDA Class II; FDA product code CIC, Cresolphthalein Complexone, Calcium) made by IDG/SANZAY Corporation, cleared under FDA 510(k) K921625 on 13 May 1992 and listed in FDA GUDID since 15 Jan 2024 (UDI-DI 00850053916076), 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) K921625

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 Number00850053916076 UDI-DI Date15 Jan 2024ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK921625 Date13 May 1992DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K921625 decided 13 May 1992 Active
  • FDA GUDID UDI-DI 00850053916076 listed 15 Jan 2024 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K921625
  2. Listed FDA GUDID 00850053916076

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  • Withdrawn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
Calcium (Ca2+) IVD, reagent
Model / Ref / Catalog
1, C105
Primary DI / UDI-DI
00850053916076
510(k) Number
FDA product code
CIC
GMDN term
Calcium (Ca2+) IVD, reagent
Device class
Class II
Regulation number
862.1145
GUDID distribution status
In Commercial Distribution
Size
Total Volume — 100 Milliliter

Related devices

Category: Calcium (Ca2+) IVD, reagent

Cleared under the same submission (K921625)

and 3 more cleared under K921625

Similar devices

Other devices filed under FDA product code CIC (Cresolphthalein Complexone, Calcium).

Other devices from IDG/SANZAY Corporation

  • IDG/Sanzay 1

    Class I

  • 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)