HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK
FDA 510(k) clearance K833665 · decided 1983-11-25
Clearance details
- K-number
- K833665
- Device name
- HEMATOLOGY WRIGHT'S-GIEMSA SATIN PACK
- Applicant
- J.S. Medical Assoc.
- Decision
- Substantially Equivalent
- Date received
- 1983-10-18
- Decision date
- 1983-11-25
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- HYF
- 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 |
|---|---|---|
| GIEMSA STAIN (K842742) | E K Ind., Inc. | 1984-08-15 |
| QUICK STAIN WRIGHT'S GIEMSA W/BUFF (K833677) | J.S. Medical Assoc. | 1983-11-25 |
| CASE WRIGHT-GIEMSA STAIN PAK (K831131) | Case Instruments | 1983-06-08 |
Recalls involving this device
No recalls on record reference this clearance.