FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
CARESIDE CALCIUM, ORIGINAL
K Number: K983789
·
Decision Dec 17, 1998
Classifications
1
FEI Numbers
29
Registration Numbers
29
Same Product Code
46
Applicant Total
22
Review Days
51
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Basic Information
- Device Name
- CARESIDE CALCIUM, ORIGINAL
- K Number
- K983789
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1145
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Careside, Inc.
- Date Received
- October 27, 1998
- Decision Date
- December 17, 1998
- Product Code
- CJY
- 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 |
|---|---|---|---|
| CJY | Azo Dye, Calcium | FDA class 2 | 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 |
| K993634 | CARESIDE ANALYZER | Dec 2, 1999 | Substantially Equivalent |
| K992475 | CARESIDE CO2, TOTAL | Sep 15, 1999 | Substantially Equivalent |
| K991717 | CARESIDE MG | Aug 10, 1999 | Substantially Equivalent |