H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME
FDA 510(k) clearance K811721 · decided 1981-07-16
Clearance details
- K-number
- K811721
- Device name
- H-101 KAPPA,H-102 LAMBDA,H-107 LYSOZME
- Applicant
- Immulok, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-06-18
- Decision date
- 1981-07-16
- Days to decision
- 28 days
- Clearance type
- Traditional
- Product code
- DFH
- Device class
- 2
- Regulation number
- 866.5550
- Medical specialty
- Immunology
- Advisory committee
- Immunology
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.