McKesson 900-900MCK
by Mckesson Medical-Surgical Inc.
McKesson 900-900MCK is a Class II device made by Mckesson Medical-Surgical Inc., cleared under FDA 510(k) K172173 on 6 Apr 2018 and listed in FDA GUDID since 1 Sep 2018 (UDI-DI 20612479234103), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number20612479234103 | Date1 Sep 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK172173 | Date6 Apr 2018 | StatusActive |
Official records
- AccessGUDID record 20612479234103
- FDA 510(k) database K172173
Across registries
- FDA 510(k) K172173 decided 6 Apr 2018 Active
- FDA GUDID UDI-DI 20612479234103 listed 1 Sep 2018 Listed
Timeline
- Cleared FDA 510(k) K172173
- Listed FDA GUDID 20612479234103
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- McKesson
- Generic name
- Haemoglobin analyser IVD, point-of-care
- Model / reference
- 900-900MCK
- Primary DI / UDI-DI
- 20612479234103
- 510(k) Number
- FDA product code
- GKR
- GMDN term
- Haemoglobin analyser IVD, point-of-care
- Device class
- Class II
- Regulation number
- 864.5620
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Haemoglobin analyser IVD, point-of-care.