FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
K Number: K880029
·
Decision Feb 24, 1988
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
3
Applicant Total
26
Review Days
50
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Basic Information
- Device Name
- EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001
- K Number
- K880029
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3060
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Immuno-Mycologics, Inc.
- Date Received
- January 5, 1988
- Decision Date
- February 24, 1988
- Product Code
- KFH
- 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 |
|---|---|---|---|
| KFH | Antiserum, Positive Control, Blastomyces Dermatitidis | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFH), ordered by most recent decision date.
BLASTOMYCES DERMATITIDIS, ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
BLASTOMYCES DERMATITIDIS POS/CONTROL
FDA 510(k)
FDA Class 2
·Microbiology
ANTI-BLASTOMYCES CONTROL SERUM (YEAST)
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by Immuno-Mycologics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K120946 | ALPHA CRYPTOCOCCAL ANTIGEN EIA | Dec 17, 2012 | Substantially Equivalent |
| K112422 | CRAG LATERAL FLOW ASSAY (LFA) | Mar 28, 2012 | Substantially Equivalent |
| K102286 | CRAG LATERAL FLOW ASSAY (CRAG LFA) | Jul 20, 2011 | Substantially Equivalent |
| K101407 | ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102 | Jul 19, 2011 | Substantially Equivalent |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | Aug 25, 1988 | Substantially Equivalent |
| K843286 | EI-CANDIDA ENZYME IMMUNOASSAY EI1001 | Oct 1, 1984 | Substantially Equivalent |
| K831918 | LA-STAPH IDENTIFICATION SYSTEM | Jun 8, 1983 | Substantially Equivalent |
| K830837 | LA-HISTO ANTIBODY SYSTEM #HL 1001 | May 5, 1983 | Substantially Equivalent |
| K810510 | YA-CRYPTO ANTIBODY TUBE AGGLUTINATION | Mar 20, 1981 | Substantially Equivalent |
| K802427 | LA-SPORO ANTIBODY SYSTEM | Oct 31, 1980 | Substantially Equivalent |