JMF — Radioimmunoassay, Human Placental Lactogen Class II
FDA Device Classification
Classification Details
- Product Code
- JMF
- Device Class
- Class II
- Regulation Number
- 862.1585
- Submission Type
- Review Panel
- CH
- Medical Specialty
- Clinical Chemistry
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|
| K944933 | diagnostic products | IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) | March 10, 1995 |
| K840588 | amersham | AMERLEX HUMAN PLACENTAL LACTOGEN | April 4, 1984 |
| K823292 | corning medical and scientific | IMMOPHASE TM HPL RADIOIMMUNOASSAY | December 28, 1982 |
| K823201 | diagnostic products | HUMAN PLACENTAL LACTOGEN KIT | November 29, 1982 |
| K811370 | armkel | NATAL-TEC HPL | May 29, 1981 |
| K802454 | syn-kit | GESTE FOLLOW KIT DETERM. OF HPL | November 12, 1980 |
| K791854 | union carbide | CENTRIA HPL RIA | October 1, 1979 |
| K790919 | technia diagnostics | HPL RIA KIT | June 28, 1979 |
| K782099 | nordiclab intl | RIA TEST, NORDICALB HPL | January 10, 1979 |
| K771656 | abbott laboratories | PROLACTIN RIA DIAG. KIT | September 22, 1977 |
| K770659 | miles laboratories | RIALYZE HPL (RIA) | May 20, 1977 |