FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALBUMIN REAGENT
K Number: K890333
·
Decision Feb 17, 1989
Classifications
1
FEI Numbers
159
Registration Numbers
159
Same Product Code
8
Applicant Total
33
Review Days
25
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
- ALBUMIN REAGENT
- K Number
- K890333
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 872.4565
- Medical Specialty
- Dental
- Decision
- Substantially Equivalent
- Applicant
- Alpkem Corp.
- Date Received
- January 23, 1989
- Decision Date
- February 17, 1989
- Product Code
- EIX
- Advisory Committee
- Dental
- Review Advisory Committee
- CH
- 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 |
|---|---|---|---|
| EIX | Probe, Periodontic | FDA class 1 | Dental |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (EIX), ordered by most recent decision date.
VIP VICTOR INTERACTIVE PROBE
FDA 510(k)
FDA Class 1
·Dental
THE VIVACARE T.P.S. PROBE
FDA 510(k)
FDA Class 1
·Dental
PROBE TIP/PERI PROBE/PERI PROBE COMP.
FDA 510(k)
FDA Class 1
·Dental
ACCUTEK PERIODONTAL PROBE
FDA 510(k)
FDA Class 1
·Dental
FLORIDA PROBE
FDA 510(k)
FDA Class 1
·Dental
ACCUDENT ACCUPROBE
FDA 510(k)
FDA Class 1
·Dental
Other Clearances by Alpkem Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K894011 | TOTAL GALACTOSE | Jan 11, 1990 | Substantially Equivalent |
| K891070 | PHENYLALANINE (NINHYDRIN REACTION) | Oct 27, 1989 | Substantially Equivalent |
| K890334 | TOTAL CHOLESTEROL REAGENT | May 3, 1989 | Substantially Equivalent |
| K890337 | TRIGLYCERIDES - GPO REAGENT | Mar 9, 1989 | Substantially Equivalent |
| K890336 | GLUCOSE (GOD) REAGENT | Feb 27, 1989 | Substantially Equivalent |
| K890332 | RFA/2 RAPID FLOW ANALYZER W/COMPUTER | Feb 17, 1989 | Substantially Equivalent |
| K890335 | SODIUM HYDROXIDE SOLUTION, CREATININE REAG./DILU. | Feb 17, 1989 | Substantially Equivalent |
| K883020 | RFA-300 RAPID FLOW ANALYZER W/COMPUTER | Sep 2, 1988 | Substantially Equivalent |
| K860367 | MAGNESIUM (SUBSTRATE, ENZYME, REAGENT) | Apr 11, 1986 | Substantially Equivalent |
| K851990 | INTERNAL STANDARD SOLUTION, EXTERNAL STANDARD SOLU | Jun 25, 1985 | Substantially Equivalent |