VOLU-SOL NMB RETICULOCYTE STAIN
FDA 510(k) clearance K792496 · decided 1979-12-31
Clearance details
- K-number
- K792496
- Device name
- VOLU-SOL NMB RETICULOCYTE STAIN
- Applicant
- Volu Sol Medical Industries
- Decision
- Substantially Equivalent
- Date received
- 1979-12-04
- Decision date
- 1979-12-31
- Days to decision
- 27 days
- Clearance type
- Traditional
- Product code
- KQC
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- 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 |
|---|---|---|
| FIELDTEX HEMATOXYLIN (K882873) | Anatech, Ltd. | 1988-07-28 |
| GENERAL DIAGNOSTICS COAG-A-MATE XC (K852843) | Warner-Lambert Co. | 1985-08-13 |
| RETIC-SET (K843619) | R&D Systems, Inc. | 1984-10-30 |
| RETIC-SET (K841848) | R&D Systems, Inc. | 1984-05-31 |
| PONCEAU S STAIN SET (K792550) | Electrophoresis Corp. of America | 1980-01-16 |
| STAT DIFF STAIN (K791007) | Bioscientific | 1979-08-03 |
| HEMASTAIN FIXATIVE (K760485) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
| HEMASTAIN PHOSPHATE BUFFER (K760487) | Geometric Data, Div. Smithkline Corp. | 1976-08-30 |
Recalls involving this device
No recalls on record reference this clearance.