FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARESIDE HDL-CHOLESTEROL
K Number: K981899
·
Decision Jul 14, 1998
Classifications
1
FEI Numbers
45
Registration Numbers
45
Same Product Code
79
Applicant Total
9
Review Days
43
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Basic Information
- Device Name
- CARESIDE HDL-CHOLESTEROL
- K Number
- K981899
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1475
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exigent Diagnostics, Inc.
- Date Received
- June 1, 1998
- Decision Date
- July 14, 1998
- Product Code
- LBS
- 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 |
|---|---|---|---|
| LBS | Ldl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl | FDA class 1 | Clinical Chemistry |
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FDA 510(k)
FDA Class 1
·Clinical Chemistry
Other Clearances by Exigent Diagnostics, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K982118 | CARESIDE ANALYZER | Jul 24, 1998 | Substantially Equivalent |
| K981183 | CARESIDE GLUCOSE | May 7, 1998 | Substantially Equivalent |
| K980043 | CARESIDE CREATININE | Mar 30, 1998 | Substantially Equivalent |
| K980056 | CARESIDE ANALYZER | Mar 6, 1998 | Substantially Equivalent |
| K980057 | CARESIDE BUN | Feb 5, 1998 | Substantially Equivalent |
| K980042 | CARESIDE TOTAL PROTEIN | Feb 4, 1998 | Substantially Equivalent |
| K980041 | CARESIDE ALBUMIN | Feb 4, 1998 | Substantially Equivalent |
| K980055 | CARESIDE GLOBULIN | Jan 28, 1998 | Substantially Equivalent |