Acid Phosphatase (Acp) Reagent
FDA 510(k) K863851 · Sigma Diagnostics, Inc.
510(k) numberK863851
Submission
- Device name
- Acid Phosphatase (Acp) Reagent
- Applicant
- Sigma Diagnostics, Inc.
St. Louis, MO, US - Received
- October 2, 1986
- Decision date
- October 16, 1986
- 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 |
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| K020109 | Sigma Diagnostics Accuclot la ControlGGC · Traditional | 02/06/2002SE |
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| K012410 | Infinity Hba Kit, Models 537-A, 537-BLCP · Traditional | 10/26/2001SE |
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| K003267 | Sigma Diagnostics Auto D-Dimer, Model CRS126-ADAP · Traditional | 03/15/2001SE |
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Questions and answers
When was Acid Phosphatase (Acp) Reagent cleared by the FDA?
Acid Phosphatase (Acp) Reagent (K863851) received a 510(k) decision of Substantially Equivalent on October 16, 1986, 14 days after the submission was received.
What is the product code of K863851?
The FDA product code is CKB – Acid Phosphatase, Naphthyl Phosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.