FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
K Number: K791386
·
Decision Aug 16, 1979
Classifications
1
FEI Numbers
4
Registration Numbers
4
Same Product Code
4
Applicant Total
26
Review Days
36
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ANTI-ASPERGILLUS (MYCELIAL) CONTR SERUM
- K Number
- K791386
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3040
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- Immuno-Mycologics, Inc.
- Date Received
- July 11, 1979
- Decision Date
- August 16, 1979
- Product Code
- KFG
- 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 |
|---|---|---|---|
| KFG | Antiserum, Positive Control, Aspergillus Spp. | FDA class 1 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFG), ordered by most recent decision date.
NICOS (NON-INVASIVE CARDIAC OUTPUT SYSTEM)
FDA 510(k)
FDA Class 1
·Microbiology
ASPERGILLUS SP, ANTISERUM, POSITIVE
FDA 510(k)
FDA Class 1
·Microbiology
ASPERGILLUS SP, ANTISERUM POSITIVE
FDA 510(k)
FDA Class 1
·Microbiology
ANTI-ASPERGILLUS CONT. SER. (MYCELIAL)
FDA 510(k)
FDA Class 1
·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 |
| 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 |