CANDIDATE(R) SUPER
FDA 510(k) clearance K863499 · decided 1987-03-19
Clearance details
- K-number
- K863499
- Device name
- CANDIDATE(R) SUPER
- Applicant
- Mercia Diagnostics , Ltd.
- Decision
- Substantially Equivalent
- Date received
- 1986-09-09
- Decision date
- 1987-03-19
- Days to decision
- 191 days
- Clearance type
- Traditional
- Product code
- LRF
- Device class
- 2
- Regulation number
- 866.3165
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Guildford, Surrey England, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| ON THE SPOT CANDIDASURE (K883118) | Medi-Tech, Inc. | 1988-09-30 |
| EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (K843286) | Immuno-Mycologics, Inc. | 1984-10-01 |
Recalls involving this device
No recalls on record reference this clearance.