FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL
K Number: K881655
·
Decision May 27, 1988
Classifications
1
FEI Numbers
10
Registration Numbers
10
Same Product Code
16
Applicant Total
3
Review Days
42
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Basic Information
- Device Name
- SPECTRUM(TM) BLOOD GAS AND ELECTROLYTE CONTROL
- K Number
- K881655
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1660
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Biomedical Research & Development Laboratories, Inc.
- Date Received
- April 15, 1988
- Decision Date
- May 27, 1988
- Product Code
- JJR
- 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 |
|---|---|---|---|
| JJR | Electrolyte Controls (Assayed And Unassayed) | FDA class 1 | Clinical Chemistry |
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