Radioimmunoassay, Human Placental Lactogen
This device is a radioimmunoassay system used to measure human placental lactogen (hPL), also known as human chorionic somatomammotropin, in maternal serum or plasma during pregnancy, used to assess placental function and fetal well-being in high-risk pregnancies. It is classified as FDA Class 2, indicating moderate risk and requiring 510(k) premarket notification, under 21 CFR 862.1585, within the Clinical Chemistry medical specialty. This device is eligible for third-party 510(k) review.
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Basic Information
- Product Code
- JMF
- Device Class
- FDA class 2
- Regulation Number
- 862.1585
- Medical Specialty
- Clinical Chemistry
- Review Panel
- CH
- Submission Type
- 1
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 11 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K944933 | IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) | Mar 10, 1995 | Substantially Equivalent | Diagnostic Products Corp. |
| K840588 | AMERLEX HUMAN PLACENTAL LACTOGEN | Apr 04, 1984 | Substantially Equivalent | Amersham Corp. |
| K823292 | IMMOPHASE TM HPL RADIOIMMUNOASSAY | Dec 28, 1982 | Substantially Equivalent | Corning Medical & Scientific |
| K823201 | HUMAN PLACENTAL LACTOGEN KIT | Nov 29, 1982 | Substantially Equivalent | Diagnostic Products Corp. |
| K811370 | NATAL-TEC HPL | May 29, 1981 | Substantially Equivalent | Armkel, LLC |
| K802454 | GESTE FOLLOW KIT DETERM. OF HPL | Nov 12, 1980 | Substantially Equivalent | Syn-Kit, Inc. |
| K791854 | CENTRIA HPL RIA | Oct 01, 1979 | Substantially Equivalent | Union Carbide Corp. |
| K790919 | HPL RIA KIT | Jun 28, 1979 | Substantially Equivalent | Technia Diagnostics , Ltd. |
| K782099 | RIA TEST, NORDICALB HPL | Jan 10, 1979 | Substantially Equivalent | Nordiclab Intl. |
| K771656 | PROLACTIN RIA DIAG. KIT | Sep 22, 1977 | Substantially Equivalent | Abbott Laboratories |
| K770659 | RIALYZE HPL (RIA) | May 20, 1977 | Substantially Equivalent | Miles Laboratories, Inc. |
FEI Numbers
This FDA classification entry is associated with 3 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 3 registration numbers. Click on an entry to view related FDA registrations.