Data / Medical devices / Acid Phosphatase, Naphthyl Phosphate
Acid Phosphatase, Naphthyl Phosphate (CKB): 8 FDA-registered makers in 3 countries
8 establishments in 3 countries are registered with the FDA to make Acid Phosphatase, Naphthyl Phosphate (product code CKB, Class 2, 21 CFR 862.1020). 5 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 24 510(k) clearances under this code, the latest on April 26, 2006, and lists 2 recall events (0 Class I). FDA data exported November 2, 2026.
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- Product code
- CKB
- Device class
- 2
- Regulation
- 862.1020
- Medical specialty
- Clinical Chemistry
Makers by country
| Country | Makers |
|---|---|
| United States | 5 |
| Japan | 2 |
| United Kingdom | 1 |
Makers of Acid Phosphatase, Naphthyl Phosphate
Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Abbott Laboratories | Irving, TX, United States | Specification developer | 1 | May 19, 1999 | 0 | 0 | 0 | api.fda.gov |
| Beckman Coulter K. K. | Sunto-Gun Shizuoka, Japan | Specification developer | 1 | June 9, 1998 | 0 | 0 | 0 | api.fda.gov |
| Fisher Diagnostics | Middletown, VA, United States | Contract manufacturer, Manufacturer | 1 | April 18, 1988 | 0 | 0 | 0 | api.fda.gov |
| Siemens Healthcare Diagnostics Inc. | Tarrytown, NY, United States | Complaint file establishment, Specification developer | 1 | January 7, 2003 | 0 | 0 | 0 | api.fda.gov |
| Teco Diagnostics | Anaheim, CA, United States | Manufacturer | 1 | July 16, 1990 | 0 | 0 | 0 | api.fda.gov |
| Bialex Lab | Wichita Falls, TX, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Beckman Coulter Mishima K.K. | SUNTO-GUN Shizuoka, Japan | Contract manufacturer | 0 | 0 | 1 | 0 | api.fda.gov | |
| Randox Laboratories Limited | CRUMLIN, COUNTY ANTRIM Antrim and Newtownabbey, United Kingdom | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated April 26, 2006. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.