FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
TDX(R) LITES(TM) LITHIUM
K Number: K894328
·
Decision Nov 13, 1989
Classifications
1
FEI Numbers
15
Registration Numbers
15
Same Product Code
11
Applicant Total
883
Review Days
122
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Basic Information
- Device Name
- TDX(R) LITES(TM) LITHIUM
- K Number
- K894328
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.3560
- Medical Specialty
- Clinical Toxicology
- Decision
- Substantially Equivalent
- Applicant
- Abbott Laboratories
- Date Received
- July 14, 1989
- Decision Date
- November 13, 1989
- Product Code
- JIH
- Advisory Committee
- Clinical Toxicology
- 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 |
|---|---|---|---|
| JIH | Flame Photometry, Lithium | FDA class 2 | Clinical Toxicology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JIH), ordered by most recent decision date.
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