FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH
K Number: K770606
·
Decision May 6, 1977
Classifications
1
FEI Numbers
39
Registration Numbers
39
Same Product Code
180
Applicant Total
11
Review Days
36
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Basic Information
- Device Name
- ANALYZEO, PLASMA, BLOOD, COLYSAGRAPH
- K Number
- K770606
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 864.5425
- Medical Specialty
- Hematology
- Decision
- Substantially Equivalent
- Applicant
- Damon Corp.
- Date Received
- March 31, 1977
- Decision Date
- May 6, 1977
- Product Code
- JPA
- Advisory Committee
- Hematology
- 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 |
|---|---|---|---|
| JPA | System, Multipurpose For In Vitro Coagulation Studies | FDA class 2 | Hematology |
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| 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 |
| 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 |
| K761013 | SPINETTE CENTRIFUGE | Nov 16, 1976 | Substantially Equivalent |