FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
K Number: K812741
·
Decision Oct 23, 1981
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
3
Applicant Total
5
Review Days
24
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Basic Information
- Device Name
- REAGENTS FOR SERODIAGNOSIS OF CANDIDOSIS
- K Number
- K812741
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3165
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Nolan Biological Laboratories, Inc.
- Date Received
- September 29, 1981
- Decision Date
- October 23, 1981
- 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
FDA 510(k)
FDA Class 2
·Microbiology
CANDIDA DETECTION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
CANDIDA IMMUNODIFFUSION SYSTEM
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Nolan Biological Laboratories, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K812740 | REAGENTS FOR SERODIAGNOSIS OF ASPERGILL | Oct 20, 1981 | Substantially Equivalent |
| K802129 | IMMUNODIFFUSION REAGENTS/SEROLOGICAL | Sep 26, 1980 | Substantially Equivalent |
| K802130 | IMMUNO. IDENTIFICATION OF H. CAPSULATUM | Sep 26, 1980 | Substantially Equivalent |
| K802128 | IMMUNODIFFUSSION REAGENTS/SEROLOGICAL | Sep 26, 1980 | Substantially Equivalent |