Seralyzer Reflectance Photometer/Calib.
FDA 510(k) K800524 · Miles Laboratories, Inc.
510(k) numberK800524
Submission
- Device name
- Seralyzer Reflectance Photometer/Calib.
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- March 6, 1980
- Decision date
- April 2, 1980
- 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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|---|---|---|---|
| K904761 | P/N 35310, Il Test Alkaline Phosphatase ReagentCIE · Traditional | Instrumentation Laboratory CO | 11/20/1990SE |
| 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 |
| K771610 | Carbon Dioxide AnalyzerCIE · Traditional | Corning Medical & Scientific | 10/07/1977SE |
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| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Seralyzer Reflectance Photometer/Calib. cleared by the FDA?
Seralyzer Reflectance Photometer/Calib. (K800524) received a 510(k) decision of Substantially Equivalent on April 2, 1980, 27 days after the submission was received.
What is the product code of K800524?
The FDA product code is CIE – Volumetric/Manometric, Carbon-Dioxide, a Class II (moderate risk) device regulated under 21 CFR 862.1160.