P/N 35310, Il Test Alkaline Phosphatase Reagent
FDA 510(k) K904761 · Instrumentation Laboratory CO
510(k) numberK904761
Submission
- Device name
- P/N 35310, Il Test Alkaline Phosphatase Reagent
- Applicant
- Instrumentation Laboratory CO
Lexington, MA, US - Received
- October 19, 1990
- Decision date
- November 20, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CIE – Volumetric/Manometric, Carbon-Dioxide
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1160
- Specialty
- Clinical Chemistry
Other 510(k)s with product code CIE
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|---|---|---|---|
| K880967 | Micro CO2 ApparatusCIE · Traditional | Hf Scientific, Inc. | 04/28/1988SE |
| K864313 | CO2 Reagent SetCIE · Traditional | Hf Scientific, Inc. | 03/13/1987SE |
| K832071 | Total CO2 Reagent SetCIE · Traditional | American Research Products Co. | 08/11/1983SE |
| K820091 | Airmed Smoke Evacuation & FilterCIE · Traditional | James L. Geraci & Associates, Inc. | 02/24/1982SE |
| K800524 | Seralyzer Reflectance Photometer/Calib.CIE · Traditional | Miles Laboratories, Inc. | 04/02/1980SE |
| K771610 | Carbon Dioxide AnalyzerCIE · Traditional | Corning Medical & Scientific | 10/07/1977SE |
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Questions and answers
When was P/N 35310, Il Test Alkaline Phosphatase Reagent cleared by the FDA?
P/N 35310, Il Test Alkaline Phosphatase Reagent (K904761) received a 510(k) decision of Substantially Equivalent on November 20, 1990, 32 days after the submission was received.
What is the product code of K904761?
The FDA product code is CIE – Volumetric/Manometric, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.