Prolactin Ria Diag. Kit
FDA 510(k) K771656 · Abbott Laboratories
510(k) numberK771656
Submission
- Device name
- Prolactin Ria Diag. Kit
- Applicant
- Abbott Laboratories
Abbott Park, IL, US - Received
- August 29, 1977
- Decision date
- September 22, 1977
- 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 |
| 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 |
| K770659 | Rialyze HPL (Ria)JMF · Traditional | Miles Laboratories, Inc. | 05/20/1977SE |
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Questions and answers
When was Prolactin Ria Diag. Kit cleared by the FDA?
Prolactin Ria Diag. Kit (K771656) received a 510(k) decision of Substantially Equivalent on September 22, 1977, 24 days after the submission was received.
What is the product code of K771656?
The FDA product code is JMF – Radioimmunoassay, Human Placental Lactogen, a Class II (moderate risk) device regulated under 21 CFR 862.1585.