FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
COULTER UREA NITROGEN REAGENT
K Number: K902175
·
Decision Jun 12, 1990
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
51
Review Days
29
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Basic Information
- Device Name
- COULTER UREA NITROGEN REAGENT
- K Number
- K902175
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Coulter Corp.
- Date Received
- May 14, 1990
- Decision Date
- June 12, 1990
- Product Code
- CDQ
- Advisory Committee
- Clinical Chemistry
- 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 |
|---|---|---|---|
| CDQ | Urease And Glutamic Dehydrogenase, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
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| K982172 | CYTO-STAT CD3-FITC/CD56-RDI MONOCLONAL ANTIBODY REAGENT WITH CYTO-STAT/COULTER CLONE MSIGGI-RD1/MSIGGI-FITC ISOTYPIC COL | Sep 24, 1998 | Substantially Equivalent |
| K973634 | COULTER AC.T DIFF ANALYZER | Oct 29, 1997 | Substantially Equivalent |