EXTENDSURE HBFASC CONTROL
FDA 510(k) clearance K053031 · decided 2005-12-07
Clearance details
- K-number
- K053031
- Device name
- EXTENDSURE HBFASC CONTROL
- Applicant
- Cantebury Scientific , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2005-10-27
- Decision date
- 2005-12-07
- Days to decision
- 41 days
- Clearance type
- Traditional
- Product code
- JCM
- Device class
- 2
- Regulation number
- 864.7415
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Christchurch, Canterbury, NZ
- 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 |
|---|---|---|
| HEMOGLOBIN F & A2 CONTROL (BETA-THALASSAEMIA CONTROL) (K011389) | Canterbury Health Laboratories | 2001-06-21 |
| MODIFICATION TO ABUSCREEN ONLINE FOR PHENCYCLIDINE (K983704) | Roche Diagnostic Systems, Inc. | 1999-02-10 |
| QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS (K942222) | Isolab, Inc. | 1995-01-20 |
| AFSC HEMO CONTROL #5331, AA2 HEMO CONTROL #5328 (K933086) | Helena Laboratories | 1994-10-31 |
| HEMOCARD CONTROL HB-AA, AE, FAA, FAE (K931234) | Isolab, Inc. | 1993-05-11 |
| HEMOCARD(TM) CONTROL (K924173) | Isolab, Inc. | 1992-12-01 |
| SICKLE HEMOGLOBIN (HBA/S) CONTROL SET (K913427) | Creative Laboratory Products, Inc. | 1991-11-19 |
| LYPHOCHEK(R) HEMOGLOBIN A2 CONTROL (K911347) | Bio-Rad | 1991-06-10 |
| HEMOCARD CONTROL (K910431) | Isolab, Inc. | 1991-03-11 |
| HELENA ABNORMAL HBA2 QUIK COLUMN CONTROL (K820787) | Helena Laboratories | 1982-04-08 |
| SICKLE-CHECK (K820037) | Diagnostic Technology, Inc. | 1982-02-04 |
Recalls involving this device
No recalls on record reference this clearance.