Immulite (HPL) (Human Placental Plactogen)
FDA 510(k) K944933 · Diagnostic Products Corp.
510(k) numberK944933
Submission
- Device name
- Immulite (HPL) (Human Placental Plactogen)
- Applicant
- Diagnostic Products Corp.
Los Angeles, CA, US - Received
- October 6, 1994
- Decision date
- March 10, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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 |
|---|---|---|---|
| K840588 | Amerlex Human Placental LactogenJMF · Traditional | Amersham Corp. | 04/04/1984SE |
| 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 |
|---|---|---|
| K063057 | Immulite/Immulite 1000, Immulite 2000 High Sensitivity CRPNQD · Abbreviated | 12/22/2006SE |
| K063045 | Immulite 2000, Immulite 2500 VancomycinLEH · Traditional | 12/05/2006SE |
| K060929 | Immulite 2500 Vitamin B12 Model L5KVB2-200 TEST,L5KVB6-600 Test, Immulite 2500 Folic…CDD · Special | 04/28/2006SE |
| K053533 | Immulite/Immulite 1000 Turbo Intact PTHCEW · Traditional | 02/03/2006SE |
| K034055 | Immulite 2500 Ck-Mb, 2500 Myoglobin, 2500 Stat Troponin IJHX · Special | 01/21/2004SE |
| K033234 | Immulite 2500 Automated Immunoassay AnalyzerDHA · Traditional | 12/12/2003SE |
| K032881 | Immulite/Immulite 1000 Total Testosterone and Immulite 2000 Total TestosteroneCDZ · Special | 10/10/2003SE |
| K023152 | Immulite 2000 Allergen-Specific IgeDHB · Abbreviated | 12/17/2002SE |
| K023304 | Immulite/Immulite 1000 Calcitonin, Model LKCL and Immulite 2000 Calcitonin, Model L2KCLJKR · Traditional | 12/09/2002SE |
| K022603 | Immulite 1000 Automated Immunoassay AnalyzerCEW · Special | 08/21/2002SE |
Questions and answers
When was Immulite (HPL) (Human Placental Plactogen) cleared by the FDA?
Immulite (HPL) (Human Placental Plactogen) (K944933) received a 510(k) decision of Substantially Equivalent on March 10, 1995, 155 days after the submission was received.
What is the product code of K944933?
The FDA product code is JMF – Radioimmunoassay, Human Placental Lactogen, a Class II (moderate risk) device regulated under 21 CFR 862.1585.