FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
AUTO. WELL TYPE GAMMA COUNTERS
K Number: K771614
·
Decision Apr 12, 1978
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
4
Review Days
232
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- AUTO. WELL TYPE GAMMA COUNTERS
- K Number
- K771614
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Actus, Inc.
- Date Received
- August 23, 1977
- Decision Date
- April 12, 1978
- 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 |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JJJ), ordered by most recent decision date.
SEQUENTIAL SAMPLE MULTI-PHOTON DETECTOR
FDA 510(k)
FDA Class 1
·Clinical Chemistry
CAPRA (CAPRAC-R) WIPETEST AND WELL COUNTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
ABBOTT VERTEX ANALYZER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
GENESYS 6000 GAMMA COUNTER
FDA 510(k)
FDA Class 1
·Clinical Chemistry
MATRIX(TM)-96
FDA 510(k)
FDA Class 1
·Clinical Chemistry
SOURCERER
FDA 510(k)
FDA Class 1
·Clinical Chemistry