Demand Acid Phosphatase Reagent
FDA 510(k) K853949 · Cooper Biomedical, Inc.
510(k) numberK853949
Submission
- Device name
- Demand Acid Phosphatase Reagent
- Applicant
- Cooper Biomedical, Inc.
Malvern, PA, US - Received
- September 24, 1985
- Decision date
- October 16, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
| 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 |
More from Medical Analysis Systems, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K864512 | Immuno-Plate IV Radial Immuno Test Kit/Human HaptoDAD · Traditional | 02/13/1987SE |
| K863868 | Immuno-Plate IV Radial Immuno Test KIT/ALPHA-1 AntDFF · Traditional | 02/13/1987SE |
| K863301 | Demand Total ProteinCEK · Traditional | 09/26/1986SE |
| K861926 | Worthington HDL Precipitating Reagent SetLBR · Traditional | 06/27/1986SE |
| K854130 | Demand Ethyl AlcoholDIC · Traditional | 11/05/1985SE |
| K852262 | Assist Clinical Chemistry AnalyzerJJE · Traditional | 06/25/1985SE |
| K851285 | Radial Immunodiffusion Plates CSF Igg & CSF AlbumiDCF · Traditional | 06/17/1985SE |
| K851284 | Radial Immuno-Diffusion Plates Iga, Igd, Igg & IgmCZP · Traditional | 06/11/1985SE |
| K851286 | Radial Immunodiffusion Plates C3 & C4CZW · Traditional | 06/05/1985SE |
| K851287 | Radial Immunodiffusion Plates TransferrinDDG · Traditional | 05/24/1985SE |
Questions and answers
When was Demand Acid Phosphatase Reagent cleared by the FDA?
Demand Acid Phosphatase Reagent (K853949) received a 510(k) decision of Substantially Equivalent on October 16, 1985, 22 days after the submission was received.
What is the product code of K853949?
The FDA product code is CKB – Acid Phosphatase, Naphthyl Phosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.