510(k) K830460
- Device
- ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE
- Applicant
- HOFFMANN-LA ROCHE, INC.
- 510(k) number
- K830460
- Product code
- DOE
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1983-03-24
- Date received
- 1983-02-15
- Regulation
- 862.3640
- Classification name
- Radioimmunoassay, Morphine (125-i), Goat Antibody Ammonium Sulfate Sep.
- Medical specialty
- Toxicology
- Review panel
- Toxicology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
FDA Registration Numbers#
- 2060833
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code DOE #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K010079 | INSTANT-VIEW MORPHINE (2000) URINE DIP STRIP TEST | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K010080 | INSTANT-VIEW MORPHINE (2000) URINE CASSETTE TEST | Alfa Scientific Designs, Inc. | 2001-05-29 |
| K011011 | LIVESURE MORPHINE SCREEN TEST | Pan Probe Biotech, Inc. | 2001-04-13 |
| K002418 | BRANAN MEDICAL CORPORATION MONITECT MORPHINE 300 DRUG SCREEN TEST, MODEL 133C AND 133D | Branan Medical Corporation | 2000-11-22 |
| K951319 | ROCHE ABUSCREEN ONLINE FOR OPIATES 1000 TEST KIT-2000 NG/ML CUTOFF OLYMPUS AU800 INSTRUMENT APPLICATION | Roche Diagnostic Systems, Inc. | 1995-06-01 |
| K935055 | ROCHE ABUSCREEN RADIOIMMUNOASSAY FOR MORPHINE (HIGH CUT-OFF) | Roche Diagnostic Systems, Inc. | 1994-08-09 |
| K933572 | URINE HEROIN/MORPHINE DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1994-04-06 |
| K881102 | MICROMEDIC MORPHINE RIA KIT | Icn Micromedic Systems | 1988-06-24 |
| K863913 | THE DPC COAT-A-COUNT SERUM MORPHINE RIA KIT | Diagnostic Products Corp. | 1987-03-19 |
| K864168 | MORPHINE ROCHE (R) EIA TEST | Roche Diagnostic Systems, Inc. | 1987-03-16 |
| K830462 | ABUSCREEN RADIOUMMUNOASSAY--URINE | Hoffmann-La Roche, Inc. | 1983-03-24 |
Legacy Summary#
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FDA Review#
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