FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
UREA NITROGEN REAGENT SET
K Number: K840064
·
Decision Jun 14, 1984
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
116
Applicant Total
15
Review Days
157
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
- UREA NITROGEN REAGENT SET
- K Number
- K840064
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1770
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Sterling Biochemical, Inc.
- Date Received
- January 9, 1984
- Decision Date
- June 14, 1984
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDQ), ordered by most recent decision date.
Urea Nitrogen2
FDA 510(k)
FDA Class 2
·Clinical Chemistry
BS-480 CHEMISTRY ANALYZER, BS-490 CHEMISTRY ANALYZER, CLC720I CHEMISTRY ANALYZER
FDA 510(k)
FDA Class 2
·Clinical Chemistry
EASYRA UREA NITROGEN AND CREATININE REAGENTS
FDA 510(k)
FDA Class 2
·Clinical Chemistry
UREA/BUN, SCAL, NORTROL, ABTROL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
ABX PENTRA GLUCOSE HK CP, UREA CP, URIC ACID CP
FDA 510(k)
FDA Class 2
·Clinical Chemistry
TECO CX3 REAGENT SET FOR SYNCHRON CX SYSTEM
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Sterling Biochemical, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K844998 | GLUCOSE(HEXOKINASE) REAGENT SET | Jan 18, 1985 | Substantially Equivalent |
| K844251 | ALT/GPT REAGENT SET | Jan 8, 1985 | Substantially Equivalent |
| K843332 | ALKALINE PHOSPHATASE REAGENT SET | Sep 14, 1984 | Substantially Equivalent |
| K842521 | AST/GOT REAGENT SET UV RATE | Aug 12, 1984 | Substantially Equivalent |
| K834084 | HYDROXYBUTYRATE DEHYDROGENASE REAGENT | Feb 4, 1984 | Substantially Equivalent |
| K834045 | URIC ACID REAGENT SET | Jan 30, 1984 | Substantially Equivalent |
| K833864 | AMYLASE REAGENT SET-MODIFIED CARAWAY | Jan 13, 1984 | Substantially Equivalent |
| K833062 | SERUM CHOLINESTERASE REAGENT SET | Nov 25, 1983 | Substantially Equivalent |
| K831874 | LIPASE REAGENT SET | Aug 12, 1983 | Substantially Equivalent |
| K831415 | LACTIC DEHYDROGENASE REAGENT SET | Jun 16, 1983 | Substantially Equivalent |