FDA 510(k) Applications for Medical Device Product Code "CKB"
(Acid Phosphatase, Naphthyl Phosphate)
| FDA 510(k) Number | Applicant | Device Name | Decision Date |
| K991010 | ABBOTT DIAGNOSTICS MFG., INC. | ACP | 05/19/1999 |
| K840661 | AMERICAN DADE | PARAMAX ACID PHOSPHATASE REAGENT | 04/04/1984 |
| K023840 | BAYER DIAGNOSTICS CORP. | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | 01/07/2003 |
| K053612 | BECKMAN COULTER, INC. | DRI-STAT ACID PHOSPHATASE REAGENT | 04/26/2006 |
| K823087 | BOEHRINGER MANNHEIM CORP. | BOEHRINGER MANNEHEIM DIAG. ACID PHOSPHA | 11/18/1982 |
| K853949 | COOPER BIOMEDICAL, INC. | DEMAND ACID PHOSPHATASE REAGENT | 10/16/1985 |
| K902543 | CRESTAT DIAGNOSTICS, INC. | ACID PHOSPHOTASE REAGENT TEST AND KIT | 09/07/1990 |
| K861675 | DATA MEDICAL ASSOCIATES, INC. | ACID PHOSPHATASE PROCEDURE | 05/29/1986 |
| K850902 | DATA MEDICAL ASSOCIATES, INC. | DATA ZYME ACID PHOSPHATASE PROCEDURE | 03/20/1985 |
| K875209 | DIAGNOSTIC CHEMICALS, LTD. (USA) | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | 02/01/1988 |
| K820975 | GILFORD DIAGNOSTICS | GILCHEM ACID PHOSPHATASE REAGENT | 04/26/1982 |
| K943366 | INSTRUMENTATION LABORATORY CO. | IL TEST ACID PHOSPHATASE | 01/29/1996 |
| K854223 | MARVIC INTERPHARMA, INC. | VES-TEC/VES-MATIC | 04/04/1986 |
| K892393 | MEDICAL ANALYSIS SYSTEMS, INC. | ACID PHOSPHATASE REAGENT | 07/20/1989 |
| K963640 | OLYMPUS AMERICA, INC. | OLYMPUS ACID PHOSPHATASE REAGENT | 02/18/1997 |
| K981743 | OLYMPUS AMERICA, INC. | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | 06/09/1998 |
| K831834 | REAGENTS APPLICATIONS, INC. | RAICHEM ACID PHASPHATASE REAGENT | 08/26/1983 |
| K974695 | ROCHE DIAGNOSTIC SYSTEMS, INC. | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES WITH B-GLUCURONIDASE (BNZGL) | 05/21/1998 |
| K881204 | SCLAVO, INC. | ACP KINETIC TEST (ACID PHOSPHATASE TEST) | 04/28/1988 |
| K863851 | SIGMA DIAGNOSTICS, INC. | ACID PHOSPHATASE (ACP) REAGENT | 10/16/1986 |
| K821674 | SMITH KLINE DIAGNOSTICS, INC. | SPINCHEM ACID PHOSPHATASE REAGENT | 06/22/1982 |
| K902495 | TECH INTL. CO. | ACID PHOSPHATASE REAGENT SET | 07/16/1990 |
| K884747 | TECHNICON INSTRUMENTS CORP. | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | 01/30/1989 |
| K880798 | TRACE AMERICA, INC. | ACID PHOSPHATASE REAGENT | 04/18/1988 |
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