MID-LEVEL IGG KIT CAT. NO. 9315
FDA 510(k) clearance K891299 · decided 1989-03-22
Clearance details
- K-number
- K891299
- Device name
- MID-LEVEL IGG KIT CAT. NO. 9315
- Applicant
- Helena Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1989-03-13
- Decision date
- 1989-03-22
- Days to decision
- 9 days
- Clearance type
- Traditional
- Product code
- DAQ
- Device class
- 1
- Regulation number
- 866.5540
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- 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.