Olympus Acid Phosphatase Reagent
FDA 510(k) K963640 · Olympus America, Inc.
510(k) numberK963640
Submission
- Device name
- Olympus Acid Phosphatase Reagent
- Applicant
- Olympus America, Inc.
Melville, NY, US - Received
- September 12, 1996
- Decision date
- February 18, 1997
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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 |
|---|---|---|---|
| K053612 | Dri-Stat Acid Phosphatase ReagentCKB · Traditional | Beckman Coulter, Inc. | 04/26/2006SE |
| 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 |
| 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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| K062581 | Olympus TSH Reagent, Calibrator and Control and AU3000I Immunoassay SystemJLW · Traditional | 11/29/2006SE |
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Questions and answers
When was Olympus Acid Phosphatase Reagent cleared by the FDA?
Olympus Acid Phosphatase Reagent (K963640) received a 510(k) decision of Substantially Equivalent on February 18, 1997, 159 days after the submission was received.
What is the product code of K963640?
The FDA product code is CKB – Acid Phosphatase, Naphthyl Phosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.