510(k) K913864
- Device
- PCP DIRECT RIA KIT (I-125)
- Applicant
- Immunalysis Corporation
- 510(k) number
- K913864
- Product code
- LCL
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1991-10-11
- Date received
- 1991-08-27
- Regulation
- 510(k) Premarket Notification
- Classification name
- Radioimmunoassay, Phencyclidine
- Medical specialty
- 510(k) Premarket Notification // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Links U.S. Food & Drug Administration Follow FDA En Español Search FDA Home Food Drugs Medical Devices
- Review panel
- Toxicology
- Device class
- U
- Clearance type
- Traditional
- Statement or summary
- Statement
- Third party reviewed
- No
Applicant Contact#
- Contact
- JAMES R SOARES
- Address
- 1707 Gardena Ave. Glendale CA US 91204 91204
FDA Registration Numbers#
- 1832216
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LCL #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011275 | PSYCHEMEDICS RIA PHENCYCLIDINE ASSAY | Psychemedics Corp. | 2002-02-11 |
| K994093 | AT WORK DRUG TEST, MODEL 9145-25C; MODEL 9177-25C | Phamatech | 1999-12-16 |
| K890882 | ABUSCREEN FP FOR PHENCYCLIDINE | Roche Diagnostic Systems, Inc. | 1989-03-15 |
| K882179 | EMIT HVA PHENCYCLIDINE ASSAY | Syva Co. | 1988-07-12 |
| K880011 | REVISED LABELING FOR ADX PHENCYCLIDINE | Abbott Laboratories | 1988-02-11 |
| K874626 | REVISED LABELING FOR SYVA PHENCYCLIDINE ASSAYS | Syva Co. | 1988-01-11 |
| K874484 | REVISED LABELING FOR TDX PHENCYCLIDINE | Abbott Laboratories | 1987-11-23 |
| K830481 | ABUSCREEN RADIOIMMUNOASSAY-PHENCYCLIDINE | Hoffmann-La Roche, Inc. | 1983-03-24 |
| K800514 | PHENCYCLIDINE DIRECT BLOOD RIA KIT | Immunalysis Corporation | 1980-03-19 |
| K790655 | ABUSCREEN RIA FOR PHENCYCLIDINE | Hoffmann-La Roche, Inc. | 1979-06-15 |
Legacy Summary#
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FDA Review#
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