FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
K Number: K801988
·
Decision Sep 26, 1980
Classifications
1
FEI Numbers
9
Registration Numbers
9
Same Product Code
44
Applicant Total
8
Review Days
38
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Basic Information
- Device Name
- NORDICLAB PROSTATIC ACID PHOSPHATASE RIA
- K Number
- K801988
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1020
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nordiclab Intl.
- Date Received
- August 19, 1980
- Decision Date
- September 26, 1980
- Product Code
- JFH
- 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 |
|---|---|---|---|
| JFH | Acid Phosphatase (Prostatic), Tartrate Inhibited | FDA class 2 | Clinical Chemistry |
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Other Clearances by Nordiclab Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K801989 | NORDICLAB FERRITIN IRMA TEST | Sep 16, 1980 | Substantially Equivalent |
| K800922 | NORDICLAB PROGESTERONE RIA TEST | May 14, 1980 | Substantially Equivalent |
| K800921 | NORDICLAB TESTOSTERONE RIA TEST | May 14, 1980 | Substantially Equivalent |
| K800920 | NORDICLAB ESTRADIOL RIA TEST | May 14, 1980 | Substantially Equivalent |
| K792189 | NORDICLAB TOTAL ESTRIOL RIA TEST | Nov 13, 1979 | Substantially Equivalent |
| K782157 | IRMA TEST, NORDICLAB FERRITIN | Jan 17, 1979 | Substantially Equivalent |
| K782099 | RIA TEST, NORDICALB HPL | Jan 10, 1979 | Substantially Equivalent |