FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
STAPHYLOCOCCUS LATEX AGGLUTINATION KIT
K Number: K820683
·
Decision Apr 14, 1982
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
12
Applicant Total
28
Review Days
34
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Basic Information
- Device Name
- STAPHYLOCOCCUS LATEX AGGLUTINATION KIT
- K Number
- K820683
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 866.3700
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Applicant
- American Scientific Products
- Date Received
- March 11, 1982
- Decision Date
- April 14, 1982
- Product Code
- LHT
- 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 |
|---|---|---|---|
| LHT | Staphylococcus Aureus Somatic Antigens | FDA class 1 | Microbiology |
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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 |