FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
K Number: K101407
·
Decision Jul 19, 2011
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
1
Applicant Total
26
Review Days
426
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Basic Information
- Device Name
- ALPHA HISTOPLASMA ANTIGEN EIA MODEL HAG102
- K Number
- K101407
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Immuno-Mycologics, Inc.
- Date Received
- May 19, 2010
- Decision Date
- July 19, 2011
- Product Code
- MIZ
- 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 |
|---|---|---|---|
| MIZ | Enzyme Linked Immunoabsorbent Assay, Histoplasma Capsulatum | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (MIZ), ordered by most recent decision date.
View allOther 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 |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | Aug 25, 1988 | Substantially Equivalent |
| K880029 | EXO-ANTIGEN IDENTIFICATION SYSTEM CAT.# EX1001 | Feb 24, 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 |