JMF — Radioimmunoassay, Human Placental Lactogen Class II
FDA product code JMF covers "Radioimmunoassay, Human Placental Lactogen", a Class II medical device regulated under 21 CFR 862.1585. Submissions are reviewed by the Clinical Chemistry panel. At least 11 recent 510(k) clearances have been granted under this product code.
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 |