ACID HEMOGLOBIN KIT
FDA 510(k) clearance K992199 · decided 1999-09-21
Clearance details
- K-number
- K992199
- Device name
- ACID HEMOGLOBIN KIT
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1999-06-30
- Decision date
- 1999-09-21
- Days to decision
- 83 days
- Clearance type
- Traditional
- Product code
- JBD
- Device class
- 2
- Regulation number
- 864.7440
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Beaumont, TX, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.