Phosphatase Procedure, Tekpoint Alkaline
FDA 510(k) K770453 · Icn Pharmaceuticals, Inc.
510(k) numberK770453
Submission
- Device name
- Phosphatase Procedure, Tekpoint Alkaline
- Applicant
- Icn Pharmaceuticals, Inc.
Orangeburg, NY, US - Received
- March 8, 1977
- Decision date
- May 3, 1977
- 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 |
| K781324 | Alp TestCIO · Traditional | Analytical & Research Chemicals, Inc. | 08/31/1978SE |
| K772257 | Alkaline Phosphatase Test SetCIO · Traditional | Stanbio Laboratory | 12/22/1977SE |
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| K914081 | Ican Cotton Rayon BallsFRL · Traditional | 10/09/1991SE |
| K913446 | Ican Needle CountersMMK · Traditional | 09/13/1991SE |
| K904398 | Water Column Relief ValveCAF · Traditional | 07/09/1991SE |
| K770458 | Bilirubin Procedure, Tekpoint Tot & Dir.CIG · Traditional | 05/10/1977SE |
Questions and answers
When was Phosphatase Procedure, Tekpoint Alkaline cleared by the FDA?
Phosphatase Procedure, Tekpoint Alkaline (K770453) received a 510(k) decision of Substantially Equivalent on May 3, 1977, 56 days after the submission was received.
What is the product code of K770453?
The FDA product code is CIO – Thymolphthalein Monophosphate, Alkaline Phosphatase Or Isoenzymes, a Class II (moderate risk) device regulated under 21 CFR 862.1050.