JMF
11 FDA 510(k) clearances · Product code
35 daysmedian time to decision
55 days90th percentile
11clearances measured
FDA profile
- Official device name
- Radioimmunoassay, Human Placental Lactogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1585
- Medical specialty
- Clinical Chemistry
- Flags
- Third-party review eligible
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) (K944933) | Diagnostic Products Corp. | 1995-03-10 |
| AMERLEX HUMAN PLACENTAL LACTOGEN (K840588) | Amersham Corp. | 1984-04-04 |
| IMMOPHASE TM HPL RADIOIMMUNOASSAY (K823292) | Corning Medical & Scientific | 1982-12-28 |
| HUMAN PLACENTAL LACTOGEN KIT (K823201) | Diagnostic Products Corp. | 1982-11-29 |
| NATAL-TEC HPL (K811370) | Armkel, LLC | 1981-05-29 |
| GESTE FOLLOW KIT DETERM. OF HPL (K802454) | Syn-Kit, Inc. | 1980-11-12 |
| CENTRIA HPL RIA (K791854) | Union Carbide Corp. | 1979-10-01 |
| HPL RIA KIT (K790919) | Technia Diagnostics , Ltd. | 1979-06-28 |
| RIA TEST, NORDICALB HPL (K782099) | Nordiclab Intl. | 1979-01-10 |
| PROLACTIN RIA DIAG. KIT (K771656) | Abbott Laboratories | 1977-09-22 |
| RIALYZE HPL (RIA) (K770659) | Miles Laboratories, Inc. | 1977-05-20 |
Track JMF automatically
Every clearance here is in the API, with alerts when new ones post.