ON THE SPOT CANDIDASURE
FDA 510(k) clearance K883118 · decided 1988-09-30
Clearance details
- K-number
- K883118
- Device name
- ON THE SPOT CANDIDASURE
- Applicant
- Medi-Tech, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1988-07-25
- Decision date
- 1988-09-30
- Days to decision
- 67 days
- Clearance type
- Traditional
- Product code
- LRF
- Device class
- 2
- Regulation number
- 866.3165
- Medical specialty
- Microbiology
- Advisory committee
- Microbiology
- Location
- Somerset, NJ, US
- 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 |
|---|---|---|
| CANDIDATE(R) SUPER (K863499) | Mercia Diagnostics , Ltd. | 1987-03-19 |
| EI-CANDIDA ENZYME IMMUNOASSAY EI1001 (K843286) | Immuno-Mycologics, Inc. | 1984-10-01 |
Recalls involving this device
No recalls on record reference this clearance.