RIALYZE HPL (RIA)
FDA 510(k) clearance K770659 · decided 1977-05-20
Clearance details
- K-number
- K770659
- Device name
- RIALYZE HPL (RIA)
- Applicant
- Miles Laboratories, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1977-04-07
- Decision date
- 1977-05-20
- Days to decision
- 43 days
- Clearance type
- Traditional
- Product code
- JMF
- Device class
- 2
- Regulation number
- 862.1585
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Miles Laboratories
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| IMMULITE (HPL) (HUMAN PLACENTAL PLACTOGEN) (K944933) | Diagnostic Products Corp. | 1995-03-10 |
| AMERLEX HUMAN PLACENTAL LACTOGEN (K840588) | Amersham Corp. | 1984-04-04 |
| IMMOPHASE TM HPL RADIOIMMUNOASSAY (K823292) | Corning Medical & Scientific | 1982-12-28 |
| HUMAN PLACENTAL LACTOGEN KIT (K823201) | Diagnostic Products Corp. | 1982-11-29 |
| NATAL-TEC HPL (K811370) | Armkel, LLC | 1981-05-29 |
| GESTE FOLLOW KIT DETERM. OF HPL (K802454) | Syn-Kit, Inc. | 1980-11-12 |
| CENTRIA HPL RIA (K791854) | Union Carbide Corp. | 1979-10-01 |
| HPL RIA KIT (K790919) | Technia Diagnostics , Ltd. | 1979-06-28 |
| RIA TEST, NORDICALB HPL (K782099) | Nordiclab Intl. | 1979-01-10 |
| PROLACTIN RIA DIAG. KIT (K771656) | Abbott Laboratories | 1977-09-22 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| BIOSTATOR GLUCOSE CONTROLLER (P800032/S001) | Miles Laboratories, Inc. | 1983-06-02 |
| BIOSTATOR GLUCOSE CONTROLLER (P800032) | Miles Laboratories, Inc. | 1981-05-28 |