FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
URIC ACID STD. FOR QUANT. URIC ACID
K Number: K772025
·
Decision Nov 11, 1977
Classifications
1
FEI Numbers
72
Registration Numbers
72
Same Product Code
129
Applicant Total
13
Review Days
15
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Basic Information
- Device Name
- URIC ACID STD. FOR QUANT. URIC ACID
- K Number
- K772025
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1150
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Worthington Biochemical Corp.
- Date Received
- October 27, 1977
- Decision Date
- November 11, 1977
- Product Code
- JIS
- 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 |
|---|---|---|---|
| JIS | Calibrator, Primary | FDA class 2 | Clinical Chemistry |
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Other Clearances by Worthington Biochemical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K780389 | HDL REAGENT SET FOR LIPOPROTEINS | Apr 19, 1978 | Substantially Equivalent |
| K780096 | LDH ISOENZYME CONTROL SERUM | Mar 3, 1978 | Substantially Equivalent |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | Jan 24, 1978 | Substantially Equivalent |
| K771001 | STATZYME GLUCOSE | Jul 11, 1977 | Substantially Equivalent |
| K771143 | INORGANIC PHOSPHORUS STANDARDS | Jul 11, 1977 | Substantially Equivalent |
| K770831 | STATZYME URIC ACID REAGENT | Jul 11, 1977 | Substantially Equivalent |
| K770470 | WORTHINGTON BUN | Jun 2, 1977 | Substantially Equivalent |
| K770277 | CHOLESTEROL STANDARDS | Mar 1, 1977 | Substantially Equivalent |
| K761263 | CHOLESTEROL AUTOMATED REAGENT | Dec 29, 1976 | Substantially Equivalent |
| K761262 | TRIGLYCERIDES (LIPASE) REAGENT SET | Dec 29, 1976 | Substantially Equivalent |