HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
FDA 510(k) clearance K113349 · decided 2012-07-11
Clearance details
- K-number
- K113349
- Device name
- HUMAN CH50 REAGENT PACK FOR USE ON THE SPAPLUS, HUMAN CH50 CALIBRATOR SET FOR USE ON THE SPAPLUS, HUMAN CH50 CONTROLS FO
- Applicant
- The Binding Site Group , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2011-11-14
- Decision date
- 2012-07-11
- Days to decision
- 240 days
- Clearance type
- Traditional
- Product code
- DAE
- Device class
- 2
- Regulation number
- 866.5240
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Birmingham, GB
- 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 |
|---|---|---|
| Optilite CH50 Reagent, Optilite CH50 Controls and Optilite CH50 Calibrator (K150412) | The Binding Site Group , Ltd. | 2015-08-28 |
| TOTAL HAEMOLYTIC COMPLEMENT RID KIT (K992488) | The Binding Site, Ltd. | 1999-09-17 |
| QUIDEL CH50 EQ EIA (K974111) | Quidel Corp. | 1998-07-29 |
| WAKO AUTOKIT CH50 (K954145) | Wako Chemicals USA, Inc. | 1995-12-18 |
| COMPLEMENT ACTIVATION EIA TEST SYSTEM (CAE) (K951639) | Incstar Corp. | 1995-10-13 |
Recalls involving this device
No recalls on record reference this clearance.