SGOT REAGENT SET
FDA 510(k) clearance K821209 · decided 1982-07-14
Clearance details
- K-number
- K821209
- Device name
- SGOT REAGENT SET
- Applicant
- Omega Medical Electronics
- Decision
- Substantially Equivalent
- Date received
- 1982-04-27
- Decision date
- 1982-07-14
- Days to decision
- 78 days
- Clearance type
- Traditional
- Product code
- CIQ
- Device class
- 2
- Regulation number
- 862.1100
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD) (K881173) | Tech-Co, Inc. | 1988-06-07 |
| SGOT (AST) REAGENT SET (K860216) | Sterling Diagnostics, Inc. | 1986-04-03 |
| GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET (K855189) | Technostics Intl. | 1986-01-14 |
| SGOT REAGENT SET (K844322) | Livonia Diagnostics, Inc. | 1984-11-27 |
| SGOT REAGENT SET (K841065) | Medical Specialties, Inc. | 1984-05-01 |
| SGOT REAGENT SET (K820466) | Anco Medical Reagents & Assoc. | 1982-03-11 |
Recalls involving this device
No recalls on record reference this clearance.