510(k) K770659
- Device
- RIALYZE HPL (RIA)
- Applicant
- Miles Laboratories, Inc.
- 510(k) number
- K770659
- Product code
- JMF
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-05-20
- Date received
- 1977-04-07
- Regulation
- 862.1585
- Classification name
- Radioimmunoassay, Human Placental Lactogen
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 3006198300
- 1036362
- 3002806944
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code JMF#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K944933 | IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) | Diagnostic Products Corp. | 1995-03-10 |
| K840588 | AMERLEX HUMAN PLACENTAL LACTOGEN | Amersham Corp. | 1984-04-04 |
| K823292 | IMMOPHASE TM HPL RADIOIMMUNOASSAY | Corning Medical & Scientific | 1982-12-28 |
| K823201 | HUMAN PLACENTAL LACTOGEN KIT | Diagnostic Products Corp. | 1982-11-29 |
| K811370 | NATAL-TEC HPL | Armkel, LLC | 1981-05-29 |
| K802454 | GESTE FOLLOW KIT DETERM. OF HPL | Syn-Kit, Inc. | 1980-11-12 |
| K790919 | HPL RIA KIT | Technia Diagnostics , Ltd. | 1979-06-28 |
| K782099 | RIA TEST, NORDICALB HPL | Nordiclab Intl. | 1979-01-10 |
| K771656 | PROLACTIN RIA DIAG. KIT | Abbott Laboratories | 1977-09-22 |