FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL
K Number: K813359
·
Decision Dec 31, 1981
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
11
Applicant Total
28
Review Days
31
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Basic Information
- Device Name
- MYCO-IMMUNE TM HISTOPLASMIN LATEX AGGL
- K Number
- K813359
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 866.3320
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- American Scientific Products
- Date Received
- November 30, 1981
- Decision Date
- December 31, 1981
- Product Code
- GMJ
- 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 |
|---|---|---|---|
| GMJ | Antigens, Histoplasma Capsulatum, All | FDA class 2 | Microbiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (GMJ), ordered by most recent decision date.
LA-HISTO ANTIBODY SYSTEM #HL 1001
FDA 510(k)
FDA Class 2
·Microbiology
IMMUNO. IDENTIFICATION OF H. CAPSULATUM
FDA 510(k)
FDA Class 2
·Microbiology
HISTOPLASMA CAPSULATUM, ANTIGEN
FDA 510(k)
FDA Class 2
·Microbiology
HISTOPLASMA CAPSULATUM, ANTIGEN YEAST
FDA 510(k)
FDA Class 2
·Microbiology
HISTOPLASMA CAPSULATUM, ANTISERUM
FDA 510(k)
FDA Class 2
·Microbiology
HISTOPLASMA CAPSULATUM, MYCELIAL PHASE
FDA 510(k)
FDA Class 2
·Microbiology
Other Clearances by American Scientific Products
| K Number | Device Name | ||
|---|---|---|---|
| K864824 | INFECTIOUS TISSUE KIT | Dec 24, 1986 | Substantially Equivalent |
| K844042 | BLOOD DILUTION VIAL | Oct 23, 1984 | Substantially Equivalent |
| K831634 | GLUCOSE REAGENT B6360-11 | Jul 19, 1983 | Substantially Equivalent |
| K831625 | UREA NITROGEN-BUN-REAGENTS B6360-12 | Jul 7, 1983 | Substantially Equivalent |
| K831626 | UREA NITROGEN-BUN-REAGENTS B6370-11A | Jul 7, 1983 | Substantially Equivalent |
| K831628 | CREATININE REAGENTS B6370-13 | Jul 6, 1983 | Substantially Equivalent |
| K831624 | GLUCOSE REAGENT KITS-B6370-10A | Jul 6, 1983 | Substantially Equivalent |
| K831627 | CREATININE REAGENTS B6360-10 | Jul 6, 1983 | Substantially Equivalent |
| K831569 | REAGENT CUPS | Jun 30, 1983 | Substantially Equivalent |
| K831571 | ROTOR | Jun 30, 1983 | Substantially Equivalent |