FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
K Number: K973938
·
Decision Feb 4, 1998
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
1
Review Days
112
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Basic Information
- Device Name
- ALPHA 4 LS AUTOMATED MICROTITERPLATE PROCESSOR AND READER
- K Number
- K973938
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Sfri, Inc.
- Date Received
- October 15, 1997
- Decision Date
- February 4, 1998
- Product Code
- JJQ
- 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 |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | FDA class 1 | Clinical Chemistry |
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