FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SERUM, URIC ACID DETERMINATION
K Number: K790019
·
Decision Feb 26, 1979
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
14
Applicant Total
89
Review Days
54
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Basic Information
- Device Name
- SERUM, URIC ACID DETERMINATION
- K Number
- K790019
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1775
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Fisher Scientific Co., LLC
- Date Received
- January 3, 1979
- Decision Date
- February 26, 1979
- Product Code
- CDH
- 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 |
|---|---|---|---|
| CDH | Acid, Uric, Phosphotungstate Reduction | FDA class 1 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (CDH), ordered by most recent decision date.
URIC ACID
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URIC ACID REAGENT SET
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URIC ACID REAGENT SET
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PHOSPHOTUNGSTATE REDUCTION, URIC ACID
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URIC ACID (TPTZ) COLORINMETRIC
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SMAC REPLACEMENT REAGENTS/DETERM-URIC-AC
FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Fisher Scientific Co., LLC
| K Number | Device Name | ||
|---|---|---|---|
| K930415 | MICROHEMATOCRIT ROTOR | Mar 23, 1993 | Substantially Equivalent |
| K915825 | MARATHON 6K GENERAL-PURPOSE CENTRIFUGE | Mar 11, 1992 | Substantially Equivalent |
| K915441 | MARATHON 13K/H MICROHEMATOCRIT CENTRIFUGE | Jan 8, 1992 | Substantially Equivalent |
| K890534 | MODIFIED URIQUAL(TM) URINALYSIS CONTROL LEVEL 1 | Mar 8, 1989 | Substantially Equivalent |
| K881275 | URIQUAL(TM) URINALYSIS CONTROLS (HUMAN) I & II | May 16, 1988 | Substantially Equivalent |
| K874054 | FISHER DIAGNOSTICS HEMATALL III LAS REAGENT | Oct 20, 1987 | Substantially Equivalent |
| K872916 | HISTOMATIC SLIDE STAINER, CODE-ON VERSION | Sep 14, 1987 | Substantially Equivalent |
| K871058 | SERACHEM LIQUID SPINAL FLUID CONTROL (HUMAN) | Apr 6, 1987 | Substantially Equivalent |
| K863224 | HEMATALL-C PLUS HEMATOLOGY CONTROLS | Oct 29, 1986 | Substantially Equivalent |
| K862318 | FISHER DIAGNOSTICS HEMATALL-C CALIBRATOR | Jul 10, 1986 | Substantially Equivalent |