ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD.— 510(k) K920184
Substantially EquivalentMbo Laboratories, Inc.
FDA 510(k) clearance K920184 for ANGEL WING SAFETY BLOOD COLLECTION WITH TUBE HOLD., Substantially Equivalent on 1992-02-18. Applicant: Mbo Laboratories, Inc.. Device class: 2.
Clearance details
- Applicant
- Mbo Laboratories, Inc.
- Product code
- Code GIM
- Device class
- Class 2
- Regulation
- 21 CFR 862.1675
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- North Chelmsford, MA, US
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More clearances from Mbo Laboratories, Inc.
view allAdverse events under product code GIM
product code GIM- Malfunction
- 1,325
- Total
- 1,325
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.