FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
CARESIDE ANALYZER
K Number: K993634
·
Decision Dec 2, 1999
Classifications
1
FEI Numbers
32
Registration Numbers
32
Same Product Code
56
Applicant Total
22
Review Days
36
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Basic Information
- Device Name
- CARESIDE ANALYZER
- K Number
- K993634
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2170
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Careside, Inc.
- Date Received
- October 27, 1999
- Decision Date
- December 2, 1999
- Product Code
- JJF
- 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 |
|---|---|---|---|
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Careside, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K020484 | CARESIDE LDH | Jul 3, 2002 | Substantially Equivalent |
| K020486 | CARESIDE GGT | Jul 1, 2002 | Substantially Equivalent |
| K020487 | CARESIDE ALT | Jun 4, 2002 | Substantially Equivalent |
| K020488 | CARESIDE TRGLYCERIDE | Apr 15, 2002 | Substantially Equivalent |
| K002792 | CARESIDE CHOLINESTERASE | Nov 8, 2000 | Substantially Equivalent |
| K001462 | CARESIDE HEMOGLOBIN | Aug 21, 2000 | Substantially Equivalent |
| K993771 | CARESIDE DIRECT BILIRUBIN | Dec 27, 1999 | Substantially Equivalent |
| K992475 | CARESIDE CO2, TOTAL | Sep 15, 1999 | Substantially Equivalent |
| K991717 | CARESIDE MG | Aug 10, 1999 | Substantially Equivalent |
| K991371 | CARESIDE AMMONIA | Aug 3, 1999 | Substantially Equivalent |