IMMULIK STAIN PLATE
FDA 510(k) clearance K812497 · decided 1981-09-23
Clearance details
- K-number
- K812497
- Device name
- IMMULIK STAIN PLATE
- Applicant
- Immulok, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1981-08-31
- Decision date
- 1981-09-23
- Days to decision
- 23 days
- Clearance type
- Traditional
- Product code
- IEG
- Device class
- 1
- Regulation number
- 864.3010
- Medical specialty
- Pathology
- Advisory committee
- Pathology
- 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.