Amerlex Human Placental Lactogen
FDA 510(k) K840588 · Amersham Corp.
510(k) numberK840588
Submission
- Device name
- Amerlex Human Placental Lactogen
- Applicant
- Amersham Corp.
Mchenry, IL, US - Received
- February 9, 1984
- Decision date
- April 4, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JMF – Radioimmunoassay, Human Placental Lactogen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1585
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JMF
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944933 | Immulite (HPL) (Human Placental Plactogen)JMF · Traditional | Diagnostic Products Corp. | 03/10/1995SE |
| K823292 | Immophase TM HPL RadioimmunoassayJMF · Traditional | Corning Medical & Scientific | 12/28/1982SE |
| K823201 | Human Placental Lactogen KitJMF · Traditional | Diagnostic Products Corp. | 11/29/1982SE |
| K811370 | Natal-Tec HPLJMF · Traditional | Armkel, LLC | 05/29/1981SE |
| K802454 | Geste Follow Kit Determ. of HPLJMF · Traditional | Syn-Kit, Inc. | 11/12/1980SE |
| K791854 | Centria HPL RiaJMF · Traditional | Union Carbide Corp. | 10/01/1979SE |
| K790919 | HPL Ria KitJMF · Traditional | Technia Diagnostics , Ltd. | 06/28/1979SE |
| K782099 | Ria Test, Nordicalb HPLJMF · Traditional | Nordiclab Intl. | 01/10/1979SE |
| K771656 | Prolactin Ria Diag. KitJMF · Traditional | Abbott Laboratories | 09/22/1977SE |
| K770659 | Rialyze HPL (Ria)JMF · Traditional | Miles Laboratories, Inc. | 05/20/1977SE |
More from Miles Laboratories, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K914135 | Amerlite(Tm) PROLACTIN-30 Assay, LAN.0086/2086CFT · Traditional | 02/18/1992SE |
| K912733 | Amerlex-M Specific Estrol(Unconjugated) Ria KitCIG · Traditional | 07/22/1991SE |
| K912766 | Amerlite Ck-Mb AssayJHY · Traditional | 07/17/1991SE |
| K904666 | Amerlite TSH-60 Assay Product Code: Lan. 0008/2008JLW · Traditional | 11/02/1990SE |
| K902760 | Amersham TSH Control SeraJJX · Traditional | 07/27/1990SE |
| K901857 | GADOLINIUM-153 Bone Densitometer (GDC.10413)KGI · Traditional | 07/09/1990SE |
| K901854 | GADOLINIUM-153 Bone Densitometer (GDC.10411/10412)KGI · Traditional | 07/09/1990SE |
| K901848 | GADOLINIUM-153 Bone Densitometer SourcesKGI · Traditional | 07/09/1990SE |
| K901832 | GADOLINIUM-153 Bone Densitometer Sources GDC.10415KGI · Traditional | 07/09/1990SE |
| K896270 | Amerlite ESTRADIOL-60 Assay LAN.0081/2081CHP · Traditional | 12/12/1989SE |
Questions and answers
When was Amerlex Human Placental Lactogen cleared by the FDA?
Amerlex Human Placental Lactogen (K840588) received a 510(k) decision of Substantially Equivalent on April 4, 1984, 55 days after the submission was received.
What is the product code of K840588?
The FDA product code is JMF – Radioimmunoassay, Human Placental Lactogen, a Class II (moderate risk) device regulated under 21 CFR 862.1585.