FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
IEC CENTRA-7 CENTRIFUGE MODEL 2362
K Number: K782124
·
Decision Feb 26, 1979
Classifications
1
FEI Numbers
163
Registration Numbers
163
Same Product Code
37
Applicant Total
11
Review Days
61
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Basic Information
- Device Name
- IEC CENTRA-7 CENTRIFUGE MODEL 2362
- K Number
- K782124
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 862.2050
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Damon Corp.
- Date Received
- December 27, 1978
- Decision Date
- February 26, 1979
- Product Code
- JQC
- 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 |
|---|---|---|---|
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 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 |
| K802661 | LIQUISOL TESTOSTERONE RADIOIMM. TEST KIT | Dec 10, 1980 | Substantially Equivalent |
| K790250 | LIQUISOL CORTISOL RIA TEST KIT | Apr 4, 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 |