CKB — Acid Phosphatase, Naphthyl Phosphate Class II
FDA product code CKB covers "Acid Phosphatase, Naphthyl Phosphate", a Class II medical device regulated under 21 CFR 862.1020. Submissions are reviewed by the Clinical Chemistry panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CKB
- Device Class
- Class II
- Regulation Number
- 862.1020
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K053612 | beckman coulter | DRI-STAT ACID PHOSPHATASE REAGENT | April 26, 2006 |
| K023840 | bayer diagnostics | ACID PHOSPHATASE ASSAY FOR THE ADVIA 1650 | January 7, 2003 |
| K991010 | abbott diagnostics mfg | ACP | May 19, 1999 |
| K981743 | olympus america | OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER | June 9, 1998 |
| K974695 | roche diagnostic systems | COBRAS INTEGRA ACID PROSTATIC PHOSPHATASE (ACPP) COBAD INTEGRA BENZODIAZEPINES W | May 21, 1998 |
| K963640 | olympus america | OLYMPUS ACID PHOSPHATASE REAGENT | February 18, 1997 |
| K943366 | instrumentation laboratory | IL TEST ACID PHOSPHATASE | January 29, 1996 |
| K902543 | crestat diagnostics | ACID PHOSPHOTASE REAGENT TEST AND KIT | September 7, 1990 |
| K902495 | tech intl | ACID PHOSPHATASE REAGENT SET | July 16, 1990 |
| K892393 | medical analysis systems | ACID PHOSPHATASE REAGENT | July 20, 1989 |
| K884747 | technicon instruments | TECHNICON CHEM 1 SYSTEM ACID PHOSPHATASE (TOTAL) | January 30, 1989 |
| K881204 | sclavo | ACP KINETIC TEST (ACID PHOSPHATASE TEST) | April 28, 1988 |
| K880798 | trace america | ACID PHOSPHATASE REAGENT | April 18, 1988 |
| K875209 | diagnostic chemicals, ltd. (usa) | ACID PHOSPHATASE (KINETIC) CAT. # 320-06 | February 1, 1988 |
| K863851 | sigma diagnostics | ACID PHOSPHATASE (ACP) REAGENT | October 16, 1986 |
| K861675 | data medical associates | ACID PHOSPHATASE PROCEDURE | May 29, 1986 |
| K854223 | marvic interpharma | VES-TEC/VES-MATIC | April 4, 1986 |
| K853949 | cooper biomedical | DEMAND ACID PHOSPHATASE REAGENT | October 16, 1985 |
| K850902 | data medical associates | DATA ZYME ACID PHOSPHATASE PROCEDURE | March 20, 1985 |
| K840661 | american dade | PARAMAX ACID PHOSPHATASE REAGENT | April 4, 1984 |