FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UREAFAST
K Number: K863076
·
Decision Sep 9, 1986
Classifications
1
FEI Numbers
2
Registration Numbers
2
Same Product Code
15
Applicant Total
34
Review Days
28
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Basic Information
- Device Name
- UREAFAST
- K Number
- K863076
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- J. D. Assoc.
- Date Received
- August 12, 1986
- Decision Date
- September 9, 1986
- Product Code
- CDL
- 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 |
|---|---|---|---|
| CDL | Berthelot Indophenol, Urea Nitrogen | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDL), ordered by most recent decision date.
RAICHEM(TM) UREA NITROGEN (COLOR) REAGENT
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STANBIO ENZYMATIC UREA NITROGEN DETERMINAT #2010
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COLORIMETRIC BUN REAGENT KIT
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UREA NITROGEN(BUN), COLORIMETRIC METHOD
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·Clinical Chemistry
UREA NITROGEN TEST
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BUN (ENZYMATIC BERTHELOT) REAGENT SET
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by J. D. Assoc.
| K Number | Device Name | ||
|---|---|---|---|
| K863103 | PEG 6,000 | Jan 13, 1987 | Substantially Equivalent |
| K863054 | AST S.C.E. (GOT) | Jan 13, 1987 | Substantially Equivalent |
| K863069 | MAGNESIOMETER | Dec 31, 1986 | Substantially Equivalent |
| K863079 | CREATINKINETIC | Dec 12, 1986 | Substantially Equivalent |
| K863112 | PROTEINMETER | Dec 10, 1986 | Substantially Equivalent |
| K863068 | LDH S.C.E. | Dec 10, 1986 | Substantially Equivalent |
| K863053 | ALT S.C.E. (GPT) | Dec 10, 1986 | Substantially Equivalent |
| K863066 | TRANSFERMETER | Dec 4, 1986 | Substantially Equivalent |
| K863109 | FERROFAST | Nov 24, 1986 | Substantially Equivalent |
| K863102 | GLUCOMETER-E | Nov 24, 1986 | Substantially Equivalent |