Acid Phosphatase Reagent Set
FDA 510(k) K902495 · Tech Intl. Co.
510(k) numberK902495
Submission
- Device name
- Acid Phosphatase Reagent Set
- Applicant
- Tech Intl. Co.
Rochester Hills, MI, US - Received
- June 5, 1990
- Decision date
- July 16, 1990
- 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 |
| 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 |
More from Technicon Instruments Corp.
| 510(k) | Device | Decision |
|---|---|---|
| K915704 | Amylase (Kinetic) Reagent SetCJD · Traditional | 06/28/1996SE |
| K915705 | Acid Phosphatase Reagent SetCKE · Traditional | 02/27/1992SE |
| K915707 | Ammonia Reagent SetJIF · Traditional | 02/26/1992SE |
| K914158 | Uric Acid Reagent SetKNK · Traditional | 02/21/1992SE |
| K915706 | Lipase Reagent SetCET · Traditional | 02/18/1992SE |
| K915710 | Amylase (Colorimetric) Reagent SetJFJ · Traditional | 01/30/1992SE |
| K914160 | Cholesterol Regeant SetCHH · Traditional | 01/30/1992SE |
| K915709 | Creatine Kinase-Mb (Ck-Mb) Reagent SetCGS · Traditional | 01/27/1992SE |
| K914159 | Glucose Reagent SetCGA · Traditional | 01/27/1992SE |
| K915708 | Inorganic Phosphorus(Colorimetric) Reagent SetCEO · Traditional | 01/22/1992SE |
Questions and answers
When was Acid Phosphatase Reagent Set cleared by the FDA?
Acid Phosphatase Reagent Set (K902495) received a 510(k) decision of Substantially Equivalent on July 16, 1990, 41 days after the submission was received.
What is the product code of K902495?
The FDA product code is CKB – Acid Phosphatase, Naphthyl Phosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.