RETICULOCYTE STAIN
FDA 510(k) clearance K875310 · decided 1988-02-09
Clearance details
- K-number
- K875310
- Device name
- RETICULOCYTE STAIN
- Applicant
- Sigma Diagnostics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1987-12-29
- Decision date
- 1988-02-09
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- KFC
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- St. Louis, MO, 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 |
|---|---|---|
| SPOTTEST LOEFFLER METHYLENE BLUE STAIN (K843919) | Difco Laboratories, Inc. | 1984-10-30 |
| METHYLENE BLUE STAIN, LOEFFLER (K842926) | E K Ind., Inc. | 1984-09-11 |
| STAIN, METHYLENE BLUE-EOSIN (K842785) | Reagent Laboratory, Inc. | 1984-09-11 |
| NEW METHYLENE BLUE N (K842743) | E K Ind., Inc. | 1984-08-12 |
| NEPHROLYTE (K831502) | Flaitron Laboratories, Inc. | 1983-07-18 |
| TUBE, STAIN, RETICULOCYTE, LARC (K770792) | Corning Medical & Scientific | 1977-07-05 |
Recalls involving this device
No recalls on record reference this clearance.