FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS
K Number: K870115
·
Decision Mar 31, 1987
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
2
Review Days
78
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Basic Information
- Device Name
- BERTHOLD LB 2103,2104-XT/PC/AT,951G GAMMA COUNTERS
- K Number
- K870115
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Berthold Analytical Instruments, Inc.
- Date Received
- January 12, 1987
- Decision Date
- March 31, 1987
- Product Code
- JJJ
- 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 |
|---|---|---|---|
| JJJ | Counter (Beta, Gamma) For Clinical Use | FDA class 1 | Clinical Chemistry |
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Other Clearances by Berthold Analytical Instruments, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K872324 | LB 9502 - CLINILUMAT, LB 952 - AUTO-CLINILUMAT | Aug 19, 1987 | Substantially Equivalent |