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Calcium Chloride 100989

by Bio/Data Corporation

Calcium Chloride 100989 (1009989) is a Class II device made by Bio/Data Corporation, cleared under FDA 510(k) K792563 on 11 Jan 1980 and listed in FDA GUDID since 30 Aug 2023 (UDI-DI G0561009890), active as of 23 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 23 Oct 2026

Documents

510(k) K792563

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 NumberG0561009890 UDI-DI Date30 Aug 2023ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK792563 Date11 Jan 1980DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K792563 decided 11 Jan 1980 Active
  • FDA GUDID UDI-DI G0561009890 listed 30 Aug 2023 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K792563
  2. Listed FDA GUDID G0561009890

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Calcium Chloride
Generic name
Calcium chloride coagulation reagent IVD
Model / Ref / Catalog
100989, 1009989
Primary DI / UDI-DI
G0561009890
510(k) Number
FDA product code
KQJ
GMDN term
Calcium chloride coagulation reagent IVD
Device class
Class II
Regulation number
864.7340
GUDID distribution status
In Commercial Distribution

Related devices

Category: Calcium chloride coagulation reagent IVD

Other devices from Bio/Data Corporation

See all devices from Bio/Data Corporation →

Properties

  • Single use
  • Contains latex
  • Prescription use
  • Lot / batch number
  • Expiration date
Other properties (10, all answered No)