510(k) K832071
- Device
- TOTAL CO2 REAGENT SET
- Applicant
- AMERICAN RESEARCH PRODUCTS CO.
- 510(k) number
- K832071
- Product code
- CIE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-08-11
- Date received
- 1983-06-27
- Regulation
- 862.1160
- Classification name
- Volumetric/manometric, Carbon-dioxide
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K904761 | P/N 35310, IL TEST ALKALINE PHOSPHATASE REAGENT | Instrumentation Laboratory CO | 1990-11-20 |
| K880967 | MICRO CO2 APPARATUS | Hf Scientific, Inc. | 1988-04-28 |
| K864313 | CO2 REAGENT SET | Hf Scientific, Inc. | 1987-03-13 |
| K820091 | AIRMED SMOKE EVACUATION & FILTER | James L. Geraci & Associates, Inc. | 1982-02-24 |
| K800524 | SERALYZER REFLECTANCE PHOTOMETER/CALIB. | Miles Laboratories, Inc. | 1980-04-02 |
| K771610 | CARBON DIOXIDE ANALYZER | Corning Medical & Scientific | 1977-10-07 |
Legacy Summary#
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FDA Review#
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