CYSTICERCOSIS SEROLOGICAL REAGENTS
FDA 510(k) clearance K900780 · decided 1990-10-04
Clearance details
- K-number
- K900780
- Device name
- CYSTICERCOSIS SEROLOGICAL REAGENTS
- Applicant
- Lmd Laboratories
- Decision
- Substantially Equivalent
- Date received
- 1990-02-20
- Decision date
- 1990-10-04
- Days to decision
- 226 days
- Clearance type
- Traditional
- Product code
- MDJ
- Device class
- 1
- Regulation number
- 866.3200
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- San Diego, CA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
No recalls on record reference this clearance.