FDA 510(k)
Substantially Equivalent
🇺🇸 United States
ASSAY SYSTEM, GAMMAFLO, AUTOMATED
K Number: K781659
·
Decision Oct 24, 1978
Classifications
0
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
32
Review Days
26
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Basic Information
- Device Name
- ASSAY SYSTEM, GAMMAFLO, AUTOMATED
- K Number
- K781659
- Clearance Type
- Traditional
- Decision
- Substantially Equivalent
- Applicant
- E. R. Squibb & Sons, Inc.
- Date Received
- September 28, 1978
- Decision Date
- October 24, 1978
- Advisory Committee
- Unknown
- Review Advisory Committee
- TX
- Third Party
- N
Other Clearances by E. R. Squibb & Sons, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K821494 | RIA STAT 16 | Jun 3, 1982 | Substantially Equivalent |
| K820616 | ANGIOTENSIS I-SQUIBB RADIOIMMUNOASSAY | Mar 26, 1982 | Substantially Equivalent |
| K820340 | T3 UPTAKE-SQUIBB DIAGNOSTIC KIT | Mar 4, 1982 | Substantially Equivalent |
| K820341 | CORTISOL-SQUIBB RADIOIMMUNOASSAY KIT | Mar 4, 1982 | Substantially Equivalent |
| K811240 | SUR-FIT LOOP OSTOMY O.R. SET | Jun 16, 1981 | Substantially Equivalent |
| K811239 | SUR-FIT DISPOSABLE CONVEX INSERT | Jun 9, 1981 | Substantially Equivalent |
| K811160 | SUR-FIT IRRIGATION SLEEVE | Jun 2, 1981 | Substantially Equivalent |
| K811163 | SUR-FIT DISPOSABLE FANGE CAP | May 21, 1981 | Substantially Equivalent |
| K810966 | DIAGOXIN SQUIBB RADIOIMMUNOASSAY KIT | Apr 21, 1981 | Substantially Equivalent |
| K810211 | T3 RIA KIT | Feb 10, 1981 | Substantially Equivalent |