Alp Test
FDA 510(k) K781324 · Analytical & Research Chemicals, Inc.
510(k) numberK781324
Submission
- Device name
- Alp Test
- Applicant
- Analytical & Research Chemicals, Inc.
Mchenry, IL, US - Received
- July 31, 1978
- Decision date
- August 31, 1978
- 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 |
| K841064 | Alkaline Phosphotase Reagent SetCIO · Traditional | Medical Specialties, Inc. | 05/01/1984SE |
| 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 |
| 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 |
|---|---|---|
| K823806 | Direct Creatinine ProcedureCGX · Traditional | 01/14/1983SE |
| K823786 | Alkaline PhosphataseCJE · Traditional | 01/14/1983SE |
| K823784 | Enzymatic Cholesterol (ColorimetricCHH · Traditional | 01/14/1983SE |
| K781460 | Chloride ReagentCHJ · Traditional | 10/10/1978SE |
| K781441 | BCG Albumin ReagetCIX · Traditional | 10/10/1978SE |
| K781323 | LDH Procedure · Traditional | 08/31/1978SE |
| K781309 | Got Procedure · Traditional | 08/31/1978SE |
| K781308 | GlucolourCGE · Traditional | 08/31/1978SE |
| K781307 | Glucose Determ. KitCGA · Traditional | 08/31/1978SE |
| K781306 | Urea Nitrogen Test KitCDL · Traditional | 08/31/1978SE |
Questions and answers
When was Alp Test cleared by the FDA?
Alp Test (K781324) received a 510(k) decision of Substantially Equivalent on August 31, 1978, 31 days after the submission was received.
What is the product code of K781324?
The FDA product code is CIO – Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.