510(k) K800681
- Device
- REAGENTS FOR DETERM. CO2 IN HUMAN SERUM
- Applicant
- DIAGNOSTIC SOLUTIONS, INC.
- 510(k) number
- K800681
- Product code
- KMS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1980-05-30
- Date received
- 1980-03-26
- Regulation
- 862.1160
- Classification name
- Phenolphthalein Colorimetry, 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 KMS #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K872886 | CARBON DIOXIDE | Catachem, Inc. | 1987-08-13 |
| K870025 | AMRESCO FLOW PAC CARBON DIOXIDE (CO2) REAGENTS | American Research Products Co. | 1987-03-13 |
| K802162 | CO2 COLOR REAGENT & CO2 SAMPLE DILUENT | Panmed, Inc. | 1980-10-10 |
| K780506 | CARBON DIOXIDE REAGENTS | Gamma Enterprises, Inc. | 1978-05-03 |
Legacy Summary#
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FDA Review#
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