FDA 510(k)
Substantially Equivalent
🇺🇸 United States
INFECTIOUS TISSUE KIT
K Number: K864824
·
Decision Dec 24, 1986
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
28
Review Days
15
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
- INFECTIOUS TISSUE KIT
- K Number
- K864824
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- American Scientific Products
- Date Received
- December 9, 1986
- Decision Date
- December 24, 1986
- Advisory Committee
- Unknown
- Review Advisory Committee
- SU
- Third Party
- N
Other Clearances by American Scientific Products
| K Number | Device Name | ||
|---|---|---|---|
| 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 |
| K822799 | STREPTACOCCUS CO-AGGLUTINATION KIT | Dec 19, 1982 | Substantially Equivalent |