Ria Test, Nordicalb HPL
FDA 510(k) K782099 · Nordiclab Intl.
510(k) numberK782099
Submission
- Device name
- Ria Test, Nordicalb HPL
- Applicant
- Nordiclab Intl.
Mchenry, IL, US - Received
- December 18, 1978
- Decision date
- January 10, 1979
- 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 |
| 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 |
|---|---|---|
| K801988 | Nordiclab Prostatic Acid Phosphatase RiaJFH · Traditional | 09/26/1980SE |
| K801989 | Nordiclab Ferritin Irma TestDBF · Traditional | 09/16/1980SE |
| K800922 | Nordiclab Progesterone Ria TestJLS · Traditional | 05/14/1980SE |
| K800921 | Nordiclab Testosterone Ria TestCDZ · Traditional | 05/14/1980SE |
| K800920 | Nordiclab Estradiol Ria TestCHP · Traditional | 05/14/1980SE |
| K792189 | Nordiclab Total Estriol Ria TestCGI · Traditional | 11/13/1979SE |
| K782157 | Irma Test, Nordiclab FerritinJMG · Traditional | 01/17/1979SE |
Questions and answers
When was Ria Test, Nordicalb HPL cleared by the FDA?
Ria Test, Nordicalb HPL (K782099) received a 510(k) decision of Substantially Equivalent on January 10, 1979, 23 days after the submission was received.
What is the product code of K782099?
The FDA product code is JMF – Radioimmunoassay, Human Placental Lactogen, a Class II (moderate risk) device regulated under 21 CFR 862.1585.