FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ON THE SPOT CANDIDASURE
K Number: K883118
·
Decision Sep 30, 1988
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
2
Applicant Total
36
Review Days
67
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Basic Information
- Device Name
- ON THE SPOT CANDIDASURE
- K Number
- K883118
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3165
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Medi-Tech, Inc.
- Date Received
- July 25, 1988
- Decision Date
- September 30, 1988
- Product Code
- LRF
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| LRF | Candida Spp., Direct Antigen, Id | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LRF), ordered by most recent decision date.
CANDIDATE(R) SUPER
FDA 510(k)
FDA Class 2
·Microbiology
EI-CANDIDA ENZYME IMMUNOASSAY EI1001
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Medi-Tech, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K954457 | MEDI-TECH EDDY INTRAVASCULAR INFUSION CATHETER | May 15, 1996 | Substantially Equivalent |
| K952345 | MEDI-TECH PLATFORM GUIDE CATHETER | Aug 17, 1995 | Substantially Equivalent |
| K952056 | IMMUNOASSAY DRUGS OF ABUSE CONTROLS | Jun 1, 1995 | Substantially Equivalent |
| K945289 | DOA - IMMUNOASSAY CUT-OFF CALIBRATOR | Dec 13, 1994 | Substantially Equivalent |
| K942551 | THERAPEUTIC DRUG MONITORING CONTROL, ASSAYED | Oct 6, 1994 | Substantially Equivalent |
| K943290 | BILIRUBIN PLUS/PEDIATRIC CONTROLS | Sep 14, 1994 | Substantially Equivalent |
| K922990 | HEMODIALYSIS BATH | Sep 12, 1994 | Substantially Equivalent |
| K942552 | THERAPEUTIC DRUG MONITORING CONTROL, UNASSAYED | Sep 9, 1994 | Substantially Equivalent |
| K904073 | COAGULATION REFERENCE PLASMA, ABNORMAL | Oct 22, 1990 | Substantially Equivalent |
| K895819 | MODIFIED LABELING TO THE SPAND-GEL GRANULATED GEL | Nov 2, 1989 | Substantially Equivalent for Some Indications |