FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA TEST KIT SYS. DAMON KIQUISOL FREE
K Number: K781012
·
Decision Jul 27, 1978
Classifications
1
FEI Numbers
43
Registration Numbers
43
Same Product Code
91
Applicant Total
11
Review Days
41
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Basic Information
- Device Name
- RIA TEST KIT SYS. DAMON KIQUISOL FREE
- K Number
- K781012
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1695
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Damon Corp.
- Date Received
- June 16, 1978
- Decision Date
- July 27, 1978
- Product Code
- CEC
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- HE
- 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 |
|---|---|---|---|
| CEC | Radioimmunoassay, Free Thyroxine | FDA class 2 | 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 |
| K802661 | LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT | Dec 10, 1980 | 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 |
| 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 |