Acid Phosphatase Reagent Set
FDA 510(k) K915705 · Tech Intl. Co.
510(k) numberK915705
Submission
- Device name
- Acid Phosphatase Reagent Set
- Applicant
- Tech Intl. Co.
Rochester Hills, MI, US - Received
- November 29, 1991
- Decision date
- February 27, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CKE – Acid Phosphatase, Thymolphthale Inmonophosphate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1020
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CKE
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K914167 | Clinical Chem.Anal.Acid,Prostatic Acid PhosphataseCKE · Traditional | Eastman Kodak Company | 03/17/1992SE |
| K873726 | Acid Phosphatase TestCKE · Traditional | King Diagnostics, Inc. | 01/27/1988SE |
| K864230 | Dimension (TM) Clinical Chemistry SystemCKE · Traditional | E.I. Dupont DE Nemours & Co., Inc. | 11/28/1986SE |
| K860476 | Acid Phosphatase Reagent SetCKE · Traditional | Sterling Diagnostics, Inc. | 03/05/1986SE |
| K843380 | Acid Phosphatase Assay KitCKE · Traditional | Diagnostic Chemicals, Ltd. (Usa) | 09/20/1984SE |
| K821526 | Acid Phosphatase Reagent SetCKE · Traditional | Anco Medical Reagents & Assoc. | 06/10/1982SE |
| K800693 | Stanbio Prostatic Acid Phosphatase TestCKE · Traditional | Stanbio Laboratory | 04/16/1980SE |
| K790524 | Data-Zyme Acia Phosphatase ProcedureCKE · Traditional | Data Medical Associates, Inc. | 05/23/1979SE |
More from Data Medical Associates, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K915704 | Amylase (Kinetic) Reagent SetCJD · Traditional | 06/28/1996SE |
| 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 |
| K914171 | In Vitro Diagnostic Regeant Set,CholinesteraseDIH · Traditional | 12/18/1991SE |
Questions and answers
When was Acid Phosphatase Reagent Set cleared by the FDA?
Acid Phosphatase Reagent Set (K915705) received a 510(k) decision of Substantially Equivalent on February 27, 1992, 90 days after the submission was received.
What is the product code of K915705?
The FDA product code is CKE – Acid Phosphatase, Thymolphthale Inmonophosphate, a Class II (moderate risk) device regulated under 21 CFR 862.1020.