FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
GAMMA GOUNTING SYS., AUTO, MODEL 1400
K Number: K771180
·
Decision Aug 3, 1977
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
62
Applicant Total
56
Review Days
34
Basic Information
- Device Name
- GAMMA GOUNTING SYS., AUTO, MODEL 1400
- K Number
- K771180
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2320
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- G.D. SEARLE AND CO.
- Date Received
- June 30, 1977
- Decision Date
- August 3, 1977
- Product Code
- JJJ
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 G.D. SEARLE AND CO.
| K Number | Device Name | ||
|---|---|---|---|
| K821159 | IN-LINE OXYGEN MONITORING SYSTEM | May 25, 1982 | Substantially Equivalent |
| K811068 | BYPASS COIL | May 27, 1981 | Substantially Equivalent |
| K811071 | VENOUS OXYGEN PROBE | May 5, 1981 | Substantially Equivalent |
| K803238 | INTRAVASCULAR CATHETER | Apr 23, 1981 | Substantially Equivalent |
| K810630 | SILICONE ELASTOMER COATED LATEX FOLEY | Mar 31, 1981 | Substantially Equivalent |
| K810131 | ADMINISTRATION SET | Feb 26, 1981 | Substantially Equivalent |
| K802485 | SEARLE VASCULAR LOOPS | Feb 12, 1981 | Substantially Equivalent |
| K801805 | METRONIDAZOLE DISCS | Feb 10, 1981 | Substantially Equivalent |
| K810112 | SWR DISPOSABLE PREP RAZOR | Feb 4, 1981 | Substantially Equivalent |
| K802280 | WHITE KNIGHT DRAPE SEAL | Oct 10, 1980 | Substantially Equivalent |