Alkaline Phosphotase Reagent Set
FDA 510(k) K841064 · Medical Specialties, Inc.
510(k) numberK841064
Submission
- Device name
- Alkaline Phosphotase Reagent Set
- Applicant
- Medical Specialties, Inc.
Mchenry, IL, US - Received
- March 12, 1984
- Decision date
- May 1, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIO – Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1050
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K880177 | Alkaline Phosphatase, Thymolphthalein MonophosphatCIO · Traditional | Tech-Co, Inc. | 04/05/1988SE |
| K860351 | Alkaline Phosphatase Reagent SetCIO · Traditional | Sterling Diagnostics, Inc. | 02/11/1986SE |
| K855192 | Alkaline Phosphatase Reagent SetCIO · Traditional | Technostics Intl. | 01/14/1986SE |
| K844498 | Sandare Alkaline Phosphatase ProcedureCIO · Traditional | Sandare Chemical Co., Inc. | 12/10/1984SE |
| K844237 | Alkaline Phosphatase Reagent SetCIO · Traditional | Livonia Diagnostics, Inc. | 11/20/1984SE |
| K823578 | Cobas Standards for Calcium-In-OrganicCIO · Traditional | Hoffmann-La Roche, Inc. | 01/07/1983SE |
| K821200 | Alkaline Phosphotase Reagent SetCIO · Traditional | Omega Medical Electronics | 07/13/1982SE |
| K781324 | Alp TestCIO · Traditional | Analytical & Research Chemicals, Inc. | 08/31/1978SE |
| K772257 | Alkaline Phosphatase Test SetCIO · Traditional | Stanbio Laboratory | 12/22/1977SE |
| K770453 | Phosphatase Procedure, Tekpoint AlkalineCIO · Traditional | Icn Pharmaceuticals, Inc. | 05/03/1977SE |
More from Icn Pharmaceuticals, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K946201 | Stand, InfusionFOX · Traditional | 04/18/1995SE |
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| K926095 | Refractrol-SpJJX · Traditional | 01/26/1993SE |
| K924926 | Msi-HctGLK · Traditional | 01/07/1993SE |
| K896566 | Modified Fox Extra Gram Negative and PositiveJWY · Traditional | 02/09/1990SE |
| K883851 | Msi-Cal 8KRZ · Traditional | 11/22/1988SE |
| K883850 | Msi-Cal 16KRZ · Traditional | 11/22/1988SE |
| K883703 | Msi-Cal 7KRZ · Traditional | 11/22/1988SE |
| K880608 | Msi-PcGJP · Traditional | 03/21/1988SE |
| K880270 | Msi-Diff PlusJPK · Traditional | 03/01/1988SE |
Questions and answers
When was Alkaline Phosphotase Reagent Set cleared by the FDA?
Alkaline Phosphotase Reagent Set (K841064) received a 510(k) decision of Substantially Equivalent on May 1, 1984, 50 days after the submission was received.
What is the product code of K841064?
The FDA product code is CIO – Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.