METRICIDE 28
FDA 510(k) clearance K931052 · decided 1994-12-06
Clearance details
- K-number
- K931052
- Device name
- METRICIDE 28
- Applicant
- Metrex Research Corp.
- Decision
- Substantially Equivalent
- Date received
- 1993-02-16
- Decision date
- 1994-12-06
- Days to decision
- 658 days
- Clearance type
- Traditional
- Product code
- MED
- Device class
- 2
- Regulation number
- 880.6885
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Parker, CO, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Metrex Research Corp.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| a. McKesson DISINFECTANT, GLUTARALDEHYDE 28DAY (4GL/CS) MGM68, Model Number: 68-102800. b. recall (Z-1614-2022) | Mckesson Medical-Surgical Inc. Corporate Office | 2022-08-26 |
| Regimen 28 Day - Glutaraldehyde Sterilizing and Disinfecting Solution recall (Z-1721-2019) | Kerr/Pentron, DBA Kerr Corporation and Pentron Clinical | 2019-07-05 |