Product code JMF— Clinical Chemistry
AMERLEX HUMAN PLACENTAL LACTOGEN
- Classification name
- Radioimmunoassay, Human Placental Lactogen
- Device class
- Class 2
- Regulation
- 21 CFR 862.1585
- Advisory panel
- Clinical Chemistry
- Total cleared
- 11
- First cleared
- Most recent
Market context for product code JMF
FDA has cleared devices under product code JMF between 1977 and 1995, filed by 10 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Clearances per year
- 1995
- 1984
- 1982
- 1981
- 1980
- 1979
- 1977
Top applicants under product code JMF
Recent clearances under product code JMF
- K944933 — IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN)
- K840588 — AMERLEX HUMAN PLACENTAL LACTOGEN
- K823292 — IMMOPHASE TM HPL RADIOIMMUNOASSAY
- K823201 — HUMAN PLACENTAL LACTOGEN KIT
- K811370 — NATAL-TEC HPL
- K802454 — GESTE FOLLOW KIT DETERM. OF HPL
- K791854 — CENTRIA HPL RIA
- K790919 — HPL RIA KIT
- K782099 — RIA TEST, NORDICALB HPL
- K771656 — PROLACTIN RIA DIAG. KIT
- K770659 — RIALYZE HPL (RIA)
Data sourced from openFDA. This site is unofficial and independent of the FDA.