QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
FDA 510(k) clearance K023335 · decided 2003-06-18
Clearance details
- K-number
- K023335
- Device name
- QCS HER2 IMMUNOCONTROLS (PRODUCT NO. C010)
- Applicant
- Qc Sciences, LLC
- Decision
- Substantially Equivalent
- Date received
- 2002-10-07
- Decision date
- 2003-06-18
- Days to decision
- 254 days
- Clearance type
- Traditional
- Product code
- NJW
- Device class
- 2
- Regulation number
- 864.1860
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Richmond, VA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| Her-2, ER, PR IHControls (K220163) | Boston Cell Standards, Inc. | 2022-08-15 |
Recalls involving this device
No recalls on record reference this clearance.