HEMATOLOGY ANALYZER
FDA 510(k) clearance K842310 · decided 1984-09-06
Clearance details
- K-number
- K842310
- Device name
- HEMATOLOGY ANALYZER
- Applicant
- Hml Inc/Biotechnology Transfer
- Decision
- Substantially Equivalent
- Date received
- 1984-06-12
- Decision date
- 1984-09-06
- Days to decision
- 86 days
- Clearance type
- Traditional
- Product code
- JKL
- Device class
- 1
- Regulation number
- 862.1060
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- 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 |
|---|---|---|
| DSL DHEA (DSL 8900) (K921534) | Diagnostic Systems Laboratories, Inc. | 1992-05-26 |
Recalls involving this device
No recalls on record reference this clearance.