Product code CKB
- Device name
- Acid Phosphatase, Naphthyl Phosphate
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1020
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K053612 | DRI-STAT ACID PHOSPHATASE REAGENT | Beckman Coulter, Inc. | 2006-04-26 |
| K023840 | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | Bayer Diagnostics Corp. | 2003-01-07 |
| K991010 | ACP | Abbott Diagnostics Mfg., Inc. | 1999-05-19 |
| K981743 | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | Olympus America, Inc. | 1998-06-09 |
| K974695 | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | Roche Diagnostic Systems, Inc. | 1998-05-21 |
| K963640 | OLYMPUS ACID PHOSPHATASE REAGENT | Olympus America, Inc. | 1997-02-18 |
| K943366 | IL TEST ACID PHOSPHATASE | Instrumentation Laboratory CO | 1996-01-29 |
| K902543 | ACID PHOSPHOTASE REAGENT TEST AND KIT | Crestat Diagnostics, Inc. | 1990-09-07 |
| K902495 | ACID PHOSPHATASE REAGENT SET | Tech Intl. Co. | 1990-07-16 |
| K892393 | ACID PHOSPHATASE REAGENT | Medical Analysis Systems, Inc. | 1989-07-20 |
| K884747 | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | Technicon Instruments Corp. | 1989-01-30 |
| K881204 | ACP KINETIC TEST (ACID PHOSPHATASE TEST) | Sclavo, Inc. | 1988-04-28 |
| K880798 | ACID PHOSPHATASE REAGENT | Trace America, Inc. | 1988-04-18 |
| K875209 | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | Diagnostic Chemicals, Ltd. (Usa) | 1988-02-01 |
| K863851 | ACID PHOSPHATASE (ACP) REAGENT | Sigma Diagnostics, Inc. | 1986-10-16 |
| K861675 | ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1986-05-29 |
| K854223 | VES-TEC/VES-MATIC | Marvic Interpharma, Inc. | 1986-04-04 |
| K853949 | DEMAND ACID PHOSPHATASE REAGENT | Cooper Biomedical, Inc. | 1985-10-16 |
| K850902 | DATA ZYME ACID PHOSPHATASE PROCEDURE | Data Medical Associates, Inc. | 1985-03-20 |
| K840661 | PARAMAX ACID PHOSPHATASE REAGENT | American Dade | 1984-04-04 |
| K831834 | RAICHEM ACID PHASPHATASE REAGENT | Reagents Applications, Inc. | 1983-08-26 |
| K823087 | BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA | Boehringer Mannheim Corp. | 1982-11-18 |
| K821674 | SPINCHEM ACID PHOSPHATASE REAGENT | Smithkline Diagnostics, Inc. | 1982-06-22 |
| K820975 | GILCHEM ACID PHOSPHATASE REAGENT | Gilford Diagnostics | 1982-04-26 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10673486001198 | ACID PHOSPHATASE REAGENT SET (KINETIC METHOD) | TECO DIAGNOSTICS | 2023-07-20 |
| 00817302024241 | CAROLINA LIQUID CHEMISTRIES CORP.® GGT REAGENT KIT CC209 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-08-19 |
| 00817302024050 | CLC GAMMA-GLUTAMYL TRANSFERASE GGT REAGENT KIT AU-209 | CAROLINA LIQUID CHEMISTRIES CORPORATION | 2022-07-06 |
| 05055273208122 | ACID PHOSPHATASE (ACP) | RANDOX LABORATORIES LIMITED | 2019-05-31 |
| 05055273200065 | ACP | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 00380740019655 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |