SODIUM CHLORIDE SOLUTION BLOOD CELL
FDA 510(k) clearance K841183 · decided 1984-05-21
Clearance details
- K-number
- K841183
- Device name
- SODIUM CHLORIDE SOLUTION BLOOD CELL
- Applicant
- Reagent Laboratory, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-03-20
- Decision date
- 1984-05-21
- Days to decision
- 62 days
- Clearance type
- Traditional
- Product code
- FNW
- Device class
- 2
- Regulation number
- 878.4370
- Medical specialty
- General, Plastic Surgery
- Advisory committee
- General, Plastic Surgery
- 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 |
|---|---|---|
| MICROMAT W/VARIOUS MODELS (K831117) | Pmt, Inc. | 1984-05-30 |
Recalls involving this device
No recalls on record reference this clearance.