FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
HDL REAGENT SET FOR LIPOPROTEINS
K Number: K780389
·
Decision Apr 19, 1978
Classifications
1
FEI Numbers
82
Registration Numbers
82
Same Product Code
229
Applicant Total
13
Review Days
40
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Basic Information
- Device Name
- HDL REAGENT SET FOR LIPOPROTEINS
- K Number
- K780389
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1175
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Worthington Biochemical Corp.
- Date Received
- March 10, 1978
- Decision Date
- April 19, 1978
- Product Code
- CHH
- 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 |
|---|---|---|---|
| CHH | Enzymatic Esterase--Oxidase, Cholesterol | FDA class 1 | Clinical Chemistry |
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Other Clearances by Worthington Biochemical Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K780096 | LDH ISOENZYME CONTROL SERUM | Mar 3, 1978 | Substantially Equivalent |
| K772356 | LDH ISOENZYME COLUMN REAGENT SET | Jan 24, 1978 | Substantially Equivalent |
| K772025 | URIC ACID STD. FOR QUANT. URIC ACID | Nov 11, 1977 | 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 |