ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
FDA 510(k) clearance K132664 · decided 2013-10-16
Clearance details
- K-number
- K132664
- Device name
- ADVIA CHEMISTRY ALBUMIN BCP REAGENT (ALBP), ADVIA CHEMISTRY ALBUMIN BCP CALIBRATOR
- Applicant
- Siemens Healthcare Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2013-08-27
- Decision date
- 2013-10-16
- Days to decision
- 50 days
- Clearance type
- Traditional
- Product code
- CJW
- Device class
- 2
- Regulation number
- 862.1035
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Tarrytown, NY, 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 |
|---|---|---|
| Albumin BCP2 (K203530) | Abbott Ireland Diagnostics Division | 2022-03-18 |
| Albumin BCP (K193001) | SENTINEL CH. SpA | 2019-12-19 |
| ALBUMIN REAGENT (K021636) | Intersect Systems, Inc. | 2002-07-17 |
| RANDOX ALBUMIN (K000483) | Randox Laboratories, Ltd. | 2000-03-31 |
| ALBUMIN BCG, MODEL AL 103-01 (K990978) | A.P. Total Care, Inc. | 1999-05-25 |
| ALBP (K981814) | Abbott Laboratories | 1998-07-22 |
| ALBP (K981457) | Abbott Mfg., Inc. | 1998-05-27 |
| ABBOTT QUICKSTART ALBUMIN BCP (ALBP)#5A16 (K913025) | Em Diagnostic Systems, Inc. | 1991-10-09 |
| ALBUMIN REAGENT SET (K905776) | Biochemical Trade, Inc. | 1991-02-26 |
| ALBUMIN (BCP) (K863226) | Sigma Diagnostics, Inc. | 1986-09-17 |
| EMDS(TM) ALBUMIN TESTPACKS, #67652/95 (K863004) | Em Diagnostic Systems, Inc. | 1986-09-16 |
| VISION ALBUMIN (K862138) | Abbott Laboratories | 1986-06-17 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| IMMULITE 2000 PSA (P930027/S039) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| IMMULITE 2000 AFP (P010007/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-07-27 |
| Atellica IM free PSA II (fPSAII) (P250026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| ADVIA Centaur AFP and Atellica IM Alpha Fetoprotein (AFP) (P930036/S026) | Siemens Healthcare Diagnostics, Inc. | 2026-05-11 |
| IMMULITE 2000 AFP (P010007/S025) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| IMMULITE 2000 PSA (P930027/S038) | Siemens Healthcare Diagnostics, Inc. | 2026-04-21 |
| Atellica IM Total PSA II (tPSAII) (P240021) | Siemens Healthcare Diagnostics, Inc. | 2025-12-03 |
| IMMULITE 2000 PSA (P930027/S037) | Siemens Healthcare Diagnostics, Inc. | 2025-10-30 |