DRI-STAT ACID PHOSPHATASE REAGENT
FDA 510(k) clearance K053612 · decided 2006-04-26
Clearance details
- K-number
- K053612
- Device name
- DRI-STAT ACID PHOSPHATASE REAGENT
- Applicant
- Beckman Coulter, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2005-12-27
- Decision date
- 2006-04-26
- Days to decision
- 120 days
- Clearance type
- Traditional
- Product code
- CKB
- Device class
- 2
- Regulation number
- 862.1020
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Brea, CA, 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 |
|---|---|---|
| ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 (K023840) | Bayer Diagnostics Corp. | 2003-01-07 |
| ACP (K991010) | Abbott Diagnostics Mfg., Inc. | 1999-05-19 |
| OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER (K981743) | Olympus America, Inc. | 1998-06-09 |
| COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) (K974695) | Roche Diagnostic Systems, Inc. | 1998-05-21 |
| OLYMPUS ACID PHOSPHATASE REAGENT (K963640) | Olympus America, Inc. | 1997-02-18 |
| IL TEST ACID PHOSPHATASE (K943366) | Instrumentation Laboratory CO | 1996-01-29 |
| ACID PHOSPHOTASE REAGENT TEST AND KIT (K902543) | Crestat Diagnostics, Inc. | 1990-09-07 |
| ACID PHOSPHATASE REAGENT SET (K902495) | Tech Intl. Co. | 1990-07-16 |
| ACID PHOSPHATASE REAGENT (K892393) | Medical Analysis Systems, Inc. | 1989-07-20 |
| TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) (K884747) | Technicon Instruments Corp. | 1989-01-30 |
| ACP KINETIC TEST (ACID PHOSPHATASE TEST) (K881204) | Sclavo, Inc. | 1988-04-28 |
| ACID PHOSPHATASE REAGENT (K880798) | Trace America, Inc. | 1988-04-18 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Access AFP (on DxI 9000 Analyzer) (P980041/S051) | Beckman Coulter, Inc. | 2025-11-03 |
| Access HBsAg, Access HBsAg Confirmatory, Access HBsAg Calibrator, Access HBsAg QC (P230015) | Beckman Coulter, Inc. | 2025-10-17 |
| Access Hybritech p2PSA (P090026/S032) | Beckman Coulter, Inc. | 2025-06-16 |
| Access Hybritech free PSA (P970038/S046) | Beckman Coulter, Inc. | 2025-05-15 |
| Access Hybritech PSA (P850048/S060) | Beckman Coulter, Inc. | 2024-09-04 |
| Access Hybritech PSA reagent pack (P850048/S059) | Beckman Coulter, Inc. | 2023-05-25 |
| Access AFP Reagents on the Access Immunoassay Systems (P980041/S050) | Beckman Coulter, Inc. | 2022-12-16 |
| Access Hybritech PSA Reagents on the Access Immunoassay Systems (P850048/S057) | Beckman Coulter, Inc. | 2022-12-16 |