Rialyze HPL (Ria)
FDA 510(k) K770659 · Miles Laboratories, Inc.
510(k) numberK770659
Submission
- Device name
- Rialyze HPL (Ria)
- Applicant
- Miles Laboratories, Inc.
Mchenry, IL, US - Received
- April 7, 1977
- Decision date
- May 20, 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 |
| K771656 | Prolactin Ria Diag. KitJMF · Traditional | Abbott Laboratories | 09/22/1977SE |
More from Abbott Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K880605 | Labeling Change for Cutter Pureflo Plus IV FilterFPB · Traditional | 05/26/1988SE |
| K874909 | Micro-Bumintest Reagent TabletsJIR · Traditional | 04/28/1988SE |
| K875079 | Modified Seralyzer Alt/Sgpt Reag. Strips & ModuleCKA · Traditional | 04/05/1988SE |
| K871835 | Glucometer QC Blood Meter, Ames Gluco System PrintCGA · Traditional | 12/22/1987SE |
| K872120 | Seralyzer III Blood Chemistry AnalyzerJJF · Traditional | 10/28/1987SE |
| K873304 | Clinitek Auto 2000 Reagent Cassette (Leukocytes)LJX · Traditional | 09/11/1987SE |
| K872634 | Cutter Pureflo Plus IV FilterFPB · Traditional | 08/04/1987SE |
| K870214 | Modified Saltex Reagent StripsCHK · Traditional | 06/29/1987SE |
| K870752 | Seralyzer Ldh/Total Bilirubin/Triglycerides StripsCFJ · Traditional | 04/14/1987SE |
| K865053 | Sera-Tek Microsomal Antibody TestJZO · Traditional | 02/18/1987SE |
Questions and answers
When was Rialyze HPL (Ria) cleared by the FDA?
Rialyze HPL (Ria) (K770659) received a 510(k) decision of Substantially Equivalent on May 20, 1977, 43 days after the submission was received.
What is the product code of K770659?
The FDA product code is JMF – Radioimmunoassay, Human Placental Lactogen, a Class II (moderate risk) device regulated under 21 CFR 862.1585.