FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RIA TEST, NORDICALB HPL
K Number: K782099
·
Decision Jan 10, 1979
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
10
Applicant Total
8
Review Days
23
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Basic Information
- Device Name
- RIA TEST, NORDICALB HPL
- K Number
- K782099
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 862.1585
- Medical Specialty
- Clinical Chemistry
- Decision
- Substantially Equivalent
- Applicant
- Nordiclab Intl.
- Date Received
- December 18, 1978
- Decision Date
- January 10, 1979
- Product Code
- JMF
- Advisory Committee
- Clinical Chemistry
- Review Advisory Committee
- IM
- 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 |
|---|---|---|---|
| JMF | Radioimmunoassay, Human Placental Lactogen | FDA class 2 | Clinical Chemistry |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (JMF), ordered by most recent decision date.
IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)
FDA 510(k)
FDA Class 2
·Clinical Chemistry
AMERLEX HUMAN PLACENTAL LACTOGEN
FDA 510(k)
FDA Class 2
·Clinical Chemistry
IMMOPHASE TM HPL RADIOIMMUNOASSAY
FDA 510(k)
FDA Class 2
·Clinical Chemistry
HUMAN PLACENTAL LACTOGEN KIT
FDA 510(k)
FDA Class 2
·Clinical Chemistry
NATAL-TEC HPL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
GESTE FOLLOW KIT DETERM. OF HPL
FDA 510(k)
FDA Class 2
·Clinical Chemistry
Other Clearances by Nordiclab Intl.
| K Number | Device Name | ||
|---|---|---|---|
| K801988 | NORDICLAB PROSTATIC ACID PHOSPHATASE RIA | Sep 26, 1980 | Substantially Equivalent |
| 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 |