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Hemoglobin AC Control HC-105

by Analytical Control Systems

Hemoglobin AC Control HC-105 is a Class II device made by Analytical Control Systems, cleared under FDA 510(k) K802569 on 12 Nov 1980 and listed in FDA GUDID since 31 Jan 2019 (UDI-DI 00817869020083), 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) K802569

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 Number00817869020083 UDI-DI Date31 Jan 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK802569 Date12 Nov 1980DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K802569 decided 12 Nov 1980 Active
  • FDA GUDID UDI-DI 00817869020083 listed 31 Jan 2019 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K802569
  2. Listed FDA GUDID 00817869020083

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Hemoglobin AC Control
Generic name
Inherited haemoglobinopathy IVD, control
Model / Ref / Catalog
HC-105
Primary DI / UDI-DI
00817869020083
510(k) Number
FDA product code
KHG
GMDN term
Inherited haemoglobinopathy IVD, control
Device class
Class II
Regulation number
864.7500
GUDID distribution status
In Commercial Distribution

Related devices

Category: Inherited haemoglobinopathy IVD, control

Cleared under the same submission (K802569)

and 8 more cleared under K802569

Similar devices

Other devices filed under FDA product code KHG (Whole Blood Hemoglobin Determination).

Other devices from Analytical Control Systems

See all devices from Analytical Control Systems →

Properties

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