FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ACCULYTE CHEMILUMINESCENCE ANALYZER
K Number: K921536
·
Decision Oct 12, 1993
Classifications
1
FEI Numbers
85
Registration Numbers
85
Same Product Code
257
Applicant Total
4
Review Days
580
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Basic Information
- Device Name
- ACCULYTE CHEMILUMINESCENCE ANALYZER
- K Number
- K921536
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2300
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Laboratory Technologies, Inc.
- Date Received
- March 11, 1992
- Decision Date
- October 12, 1993
- 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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