Her-2, ER, PR IHControls
FDA 510(k) clearance K220163 · decided 2022-08-15
Clearance details
- K-number
- K220163
- Device name
- Her-2, ER, PR IHControls
- Applicant
- Boston Cell Standards, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2022-01-20
- Decision date
- 2022-08-15
- Days to decision
- 207 days
- Clearance type
- Traditional
- Product code
- NJW
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Sharon, MA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Boston Cell Standards
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.
| Record | Firm | Date |
|---|---|---|
| QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010) (K023335) | Qc Sciences, LLC | 2003-06-18 |
Recalls involving this device
No recalls on record reference this clearance.