FDA 510(k)
FDA class 1
Substantially Equivalent
🇬🇧 United Kingdom
ASTROSCAN 2100 MICROTITER PLATE READER
K Number: K881458
·
Decision Jun 29, 1988
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
1
Review Days
83
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Basic Information
- Device Name
- ASTROSCAN 2100 MICROTITER PLATE READER
- K Number
- K881458
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Astroscan , Ltd.
- Date Received
- April 7, 1988
- Decision Date
- June 29, 1988
- Product Code
- JJQ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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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