Dri-Stat Acid Phosphatase Reagent
FDA 510(k) K053612 · Beckman Coulter, Inc.
510(k) numberK053612
Submission
- Device name
- Dri-Stat Acid Phosphatase Reagent
- Applicant
- Beckman Coulter, Inc.
Brea, CA, US - Received
- December 27, 2005
- Decision date
- April 26, 2006
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- CKB – Acid Phosphatase, Naphthyl Phosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1020
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023840 | Acid Phosphatase Assay for the Advia 1650CKB · Traditional | Bayer Diagnostics Corp. | 01/07/2003SE |
| K991010 | AcpCKB · Traditional | Abbott Diagnostics Mfg., Inc. | 05/19/1999SE |
| K981743 | Olympus AU400 Clinical Chemistry AnalyzerCKB · Special | Olympus America, Inc. | 06/09/1998SE |
| K974695 | Cobras Integra Acid Prostatic Phosphatase (Acpp) Cobad Integra Benzodiazepines with…CKB · Traditional | Roche Diagnostic Systems, Inc. | 05/21/1998SE |
| K963640 | Olympus Acid Phosphatase ReagentCKB · Traditional | Olympus America, Inc. | 02/18/1997SE |
| K943366 | Il Test Acid PhosphataseCKB · Traditional | Instrumentation Laboratory CO | 01/29/1996SE |
| K902543 | Acid Phosphotase Reagent Test and KitCKB · Traditional | Crestat Diagnostics, Inc. | 09/07/1990SE |
| K902495 | Acid Phosphatase Reagent SetCKB · Traditional | Tech Intl. Co. | 07/16/1990SE |
| K892393 | Acid Phosphatase ReagentCKB · Traditional | Medical Analysis Systems, Inc. | 07/20/1989SE |
| K884747 | Technicon Chem 1 System Acid Phosphatase (Total)CKB · Traditional | Technicon Instruments Corp. | 01/30/1989SE |
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Questions and answers
When was Dri-Stat Acid Phosphatase Reagent cleared by the FDA?
Dri-Stat Acid Phosphatase Reagent (K053612) received a 510(k) decision of Substantially Equivalent on April 26, 2006, 120 days after the submission was received.
What is the product code of K053612?
The FDA product code is CKB – Acid Phosphatase, Naphthyl Phosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.