FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CANDIDA DETECTION SYSTEM
K Number: K823016
·
Decision Dec 28, 1982
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
9
Review Days
77
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Basic Information
- Device Name
- CANDIDA DETECTION SYSTEM
- K Number
- K823016
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3165
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Ramco Laboratories, Inc.
- Date Received
- October 12, 1982
- Decision Date
- December 28, 1982
- Product Code
- LHK
- 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 |
|---|---|---|---|
| LHK | Antigen, Id, Candida Albicans | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (LHK), ordered by most recent decision date.
DIRECTIGEN 1-2-3 DISSEMINATED CANDIDIASIS TEST
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REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
FDA 510(k)
FDA Class 2
·Microbiology
CANDIDA IMMUNODIFFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Ramco Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K983107 | VFE | Oct 22, 1998 | Substantially Equivalent |
| K981208 | TFR | Oct 21, 1998 | Substantially Equivalent |
| K910481 | EPO-RIA | Nov 29, 1991 | Substantially Equivalent |
| K872941 | SPECTRO C | Sep 4, 1987 | Substantially Equivalent |
| K864701 | VWF IMMUNOBLOT | Mar 30, 1987 | Substantially Equivalent |
| K861159 | SPECTRO VWF | May 1, 1986 | Substantially Equivalent |
| K831470 | PTH MR | Jun 22, 1983 | Substantially Equivalent |
| K812056 | SPECTRO FEIRITIN | Aug 12, 1981 | Substantially Equivalent |