FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
DIRECT UREA NITROGEN TEST
K Number: K780262
·
Decision Apr 5, 1978
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
20
Applicant Total
22
Review Days
47
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Basic Information
- Device Name
- DIRECT UREA NITROGEN TEST
- K Number
- K780262
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Hycel, Inc.
- Date Received
- February 17, 1978
- Decision Date
- April 5, 1978
- Product Code
- CDW
- 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 |
|---|---|---|---|
| CDW | Diacetyl-Monoxime, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDW), ordered by most recent decision date.
BLOOD UREA NITROGEN
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FLOW-PAC UREA NITROGEN REAGENT SET 2214, 2814
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FDA Class 2
·Clinical Chemistry
AMRESCO FLOW PAC UREA NITROGEN REAGENTS #1346
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TWIN BUN/GLUCOSE
FDA 510(k)
FDA Class 2
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UREA NITROGEN REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UREA
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Hycel, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K802422 | HYCEL TRIGYCERIDE II TEST | Oct 6, 1980 | Unknown |
| K790335 | HYCEL M | Feb 27, 1979 | Substantially Equivalent |
| K782116 | KETOSTEROID TEST, HYCEL-17 | Jan 26, 1979 | Substantially Equivalent |
| K782176 | HYCEL LDH-INT TEST | Jan 26, 1979 | Substantially Equivalent |
| K782102 | HYCEL COUNTER 211 | Jan 3, 1979 | Substantially Equivalent |
| K782100 | HYCEL COUNTER 333 | Jan 3, 1979 | Substantially Equivalent |
| K782101 | HYCEL COUNTER 222 | Jan 3, 1979 | Substantially Equivalent |
| K781004 | HMA URIC ACID TEST | Jul 27, 1978 | Substantially Equivalent |
| K780946 | ROYCO MODEL 970 HEMATOLOGY DATA ANALYZER | Jul 27, 1978 | Substantially Equivalent |
| K780464 | LELECTIVE KINETIC SYSTEM-60 | May 3, 1978 | Substantially Equivalent |