ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
FDA 510(k) clearance K120183 · decided 2012-05-11
Clearance details
- K-number
- K120183
- Device name
- ADVOCATE REDI-CODE+BMB-EA001S BLOOD GLUCOSE MONITORING SYSTEM
- Applicant
- Broadmaster Biotech Corperation
- Decision
- Substantially Equivalent
- Date received
- 2012-01-23
- Decision date
- 2012-05-11
- Days to decision
- 109 days
- Clearance type
- Special
- Product code
- NBW
- Device class
- 2
- Regulation number
- 862.1345
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Zhonghe Dist, TW
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Broadmaster Biotech Corperation
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| ADVOCATE Redi-Code+ BMB-BA006A Blood Glucose test strips Product Usage: The ADVOCATE Redi- recall (Z-2021-2014) | DIABETIC SUPPLY OF SUNCOAST, INC. | 2014-07-22 |