CHOLESTEROL REAGENT SET
FDA 510(k) clearance K821195 · decided 1982-07-13
Clearance details
- K-number
- K821195
- Device name
- CHOLESTEROL REAGENT SET
- Applicant
- Omega Medical Electronics
- Decision
- Substantially Equivalent
- Date received
- 1982-04-27
- Decision date
- 1982-07-13
- Days to decision
- 77 days
- Clearance type
- Traditional
- Product code
- CHD
- Device class
- 1
- Regulation number
- 862.1175
- 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 |
|---|---|---|
| CHOLESTEROL REAGENT SET (K841052) | Medical Specialties, Inc. | 1984-05-01 |
| ACTIVATED URIC ACID (K830616) | American Monitor Corp. | 1983-04-05 |
Recalls involving this device
No recalls on record reference this clearance.