AMERLEX HUMAN PLACENTAL LACTOGEN
FDA 510(k) clearance K840588 · decided 1984-04-04
Clearance details
- K-number
- K840588
- Device name
- AMERLEX HUMAN PLACENTAL LACTOGEN
- Applicant
- Amersham Corp.
- Decision
- Substantially Equivalent
- Date received
- 1984-02-09
- Decision date
- 1984-04-04
- Days to decision
- 55 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
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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 |
| 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 |
| RIALYZE HPL (RIA) (K770659) | Miles Laboratories, Inc. | 1977-05-20 |
Recalls involving this device
No recalls on record reference this clearance.