FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT
K Number: K802661
·
Decision Dec 10, 1980
Classifications
1
FEI Numbers
56
Registration Numbers
56
Same Product Code
88
Applicant Total
11
Review Days
43
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Basic Information
- Device Name
- LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT
- K Number
- K802661
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.1680
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Damon Corp.
- Date Received
- October 28, 1980
- Decision Date
- December 10, 1980
- Product Code
- CDZ
- 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 |
|---|---|---|---|
| CDZ | Radioimmunoassay, Testosterones And Dihydrotestosterone | FDA class 1 | Clinical Chemistry |
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Other Clearances by Damon Corp.
| K Number | Device Name | ||
|---|---|---|---|
| K874865 | DAMON D.E.T.E.C.T IMAGE ENHANCER | Dec 23, 1987 | Substantially Equivalent |
| K831826 | ADRENOCORTICOTROPIN RADIO-IMMUNOASSAY | Jul 18, 1983 | Substantially Equivalent |
| K820686 | LIQUISOL PROGESTERONE RADIOIMMUNO | Apr 1, 1982 | Substantially Equivalent |
| K790250 | LIQUISOL CORTISOL RIA TEST KIT | Apr 4, 1979 | Substantially Equivalent |
| K782124 | IEC CENTRA-7 CENTRIFUGE MODEL 2362 | Feb 26, 1979 | Substantially Equivalent |
| K781012 | RIA TEST KIT SYS. DAMON KIQUISOL FREE | Jul 27, 1978 | Substantially Equivalent |
| K780207 | LIQUISOL DIGOXIN RIA TEST KIT | Feb 23, 1978 | Substantially Equivalent |
| K770918 | LIQUI SOL T4 RIA TEST KIT | Jun 17, 1977 | Substantially Equivalent |
| K770606 | ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH | May 6, 1977 | Substantially Equivalent |
| K761013 | SPINETTE CENTRIFUGE | Nov 16, 1976 | Substantially Equivalent |