510(k) K821209
- Device
- SGOT REAGENT SET
- Applicant
- OMEGA MEDICAL ELECTRONICS
- 510(k) number
- K821209
- Product code
- CIQ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-14
- Date received
- 1982-04-27
- Regulation
- 862.1100
- Classification name
- Diazo, Ast/sgot
- 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
FDA Registration Numbers#
- 1832216
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CIQ #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K881173 | ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) | Tech-Co, Inc. | 1988-06-07 |
| K860216 | SGOT (AST) REAGENT SET | Sterling Diagnostics, Inc. | 1986-04-03 |
| K855189 | GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET | Technostics Intl. | 1986-01-14 |
| K844322 | SGOT REAGENT SET | Livonia Diagnostics, Inc. | 1984-11-27 |
| K841065 | SGOT REAGENT SET | Medical Specialties, Inc. | 1984-05-01 |
| K820466 | SGOT REAGENT SET | Anco Medical Reagents & Assoc. | 1982-03-11 |
Legacy Summary#
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FDA Review#
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