510(k) K821965
- Device
- ORAL THC-CANNABINOIDS DIRECT RIA KIT
- Applicant
- Immunalysis Corporation
- 510(k) number
- K821965
- Product code
- LAT
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1982-07-20
- Date received
- 1982-07-02
- Regulation
- 862.3870
- Classification name
- Radioimmunoassay, Cannabinoid(s)
- Medical specialty
- Toxicology
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code LAT #
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K011426 | PSYCHEMEDICS RIA CANNABINOID ASSAY | Psychemedics Corp. | 2002-05-03 |
| K961620 | ABISCREEN ONLINE FOR CANNABINOIDS - ES 50/100 | Roche Diagnostic Systems, Inc. | 1996-06-13 |
| K936135 | SUDORMED SWEAT PATCH SPECIMEN CONTAINER FOR COLLECTION OF MARIJUANA IN PERSPIRATION | Sudormed, Inc. | 1996-06-10 |
| K914507 | DOUBLE ANTIBODY CANNABIONOIDS/QUAIL DETER IN URINE | Diagnostic Products Corp. | 1991-12-18 |
| K913414 | ABUSCREEN(R) ONLINE(TM) FOR THC(50/100)(100TEST KT | Roche Diagnostic Systems, Inc. | 1991-09-25 |
| K913865 | URINE THC DIRECT RIA KIT (I-125) | Immunalysis Corporation | 1991-09-18 |
| K912574 | ABUSCREEN ONLINE FOR THC (50 AND 100) | Roche Diagnostic Systems, Inc. | 1991-08-12 |
| K904996 | ABUSCREEN ONLINE TM FOR THC | Roche Diagnostic Systems, Inc. | 1991-01-11 |
| K843534 | ORAL THC-CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | 1984-10-30 |
| K833911 | URINE THC CANNABINOIDS DIRECT RIA KIT | Immunalysis Corporation | 1984-01-24 |
| K820903 | THC-CANNABINOIDS DIRECT URINE RIA KIT | Immunalysis Corporation | 1982-05-05 |
| K820391 | ABUSCREEN RADIOIMMUNOASSAY FOR CANNABI | Hoffmann-La Roche, Inc. | 1982-03-08 |
| K800246 | EMIT -D.A.U. CANNABINOID URINE ASSAY | Syva Co. | 1980-02-26 |
| K791649 | TETRAHYDROCANNALBINOL DIRECT BLOOD KIT | Immunalysis Corporation | 1979-10-11 |
| K781048 | THC DIRECT RIA KIT | Immunalysis Corporation | 1978-10-03 |
Legacy Summary#
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FDA Review#
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