FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SET, ORAL ADMINISTRATION
K Number: K760251
·
Decision Sep 15, 1976
Classifications
1
FEI Numbers
0
Registration Numbers
0
Same Product Code
0
Applicant Total
9
Review Days
58
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Basic Information
- Device Name
- SET, ORAL ADMINISTRATION
- K Number
- K760251
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 876.5980
- Medical Specialty
- Gastroenterology, Urology
- Decision
- Substantially Equivalent
- Applicant
- Cis Radiopharmaceuticals, Inc.
- Date Received
- July 19, 1976
- Decision Date
- September 15, 1976
- Product Code
- LEY
- Advisory Committee
- Gastroenterology, Urology
- Review Advisory Committee
- HO
- 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 |
|---|---|---|---|
| LEY | Set, Oral Administration | FDA class 2 | Gastroenterology, Urology |
Other Clearances by Cis Radiopharmaceuticals, Inc.
| K Number | Device Name | ||
|---|---|---|---|
| K791860 | FERRITIN RIA KIT | Dec 6, 1979 | Substantially Equivalent |
| K792063 | FOLLICLE STIMULATING HORMONE (FSH) KIT | Nov 20, 1979 | Substantially Equivalent |
| K791202 | RIA KIT FOR TRYPSIN | Nov 5, 1979 | Substantially Equivalent |
| K792000 | LUTEINIZING HORMONE (LH) RIA | Oct 30, 1979 | Substantially Equivalent |
| K791051 | PROGESTERONE RADIOIMMUNOASSAY KIT | Jul 24, 1979 | Substantially Equivalent |
| K790003 | RIA KIT, PROLACTIN | Mar 12, 1979 | Substantially Equivalent |
| K780982 | KITS, RIA, MYOGLOBIN, HUMAN, MEASUREMENT | Jun 22, 1978 | Substantially Equivalent |
| K771878 | IRIDIUM 192 WIRES & PINS | Oct 27, 1977 | Substantially Equivalent |