TUBE, STAIN, RETICULOCYTE, LARC
FDA 510(k) clearance K770792 · decided 1977-07-05
Clearance details
- K-number
- K770792
- Device name
- TUBE, STAIN, RETICULOCYTE, LARC
- Applicant
- Corning Medical & Scientific
- Decision
- Substantially Equivalent
- Date received
- 1977-05-02
- Decision date
- 1977-07-05
- Days to decision
- 64 days
- Clearance type
- Traditional
- Product code
- KFC
- Device class
- 1
- Regulation number
- 864.1850
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Corning Medical & Scientific
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| RETICULOCYTE STAIN (K875310) | Sigma Diagnostics, Inc. | 1988-02-09 |
| 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 |
Recalls involving this device
No recalls on record reference this clearance.