THC Direct Ria Kit
FDA 510(k) K781048 · Immunalysis Corporation
510(k) numberK781048
Submission
- Device name
- THC Direct Ria Kit
- Applicant
- Immunalysis Corporation
Mchenry, IL, US - Received
- June 21, 1978
- Decision date
- October 3, 1978
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LAT – Radioimmunoassay, Cannabinoid(S)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3870
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011426 | Psychemedics Ria Cannabinoid AssayLAT · Traditional | Psychemedics Corp. | 05/03/2002SE |
| K961620 | Abiscreen Online for Cannabinoids - Es 50/100LAT · Traditional | Roche Diagnostic Systems, Inc. | 06/13/1996SE |
| K936135 | Sudormed Sweat Patch Specimen Container for Collection of Marijuana in PerspirationLAT · Traditional | Sudormed, Inc. | 06/10/1996SE |
| K914507 | Double Antibody Cannabionoids/Quail Deter in UrineLAT · Traditional | Diagnostic Products Corp. | 12/18/1991SE |
| K913414 | Abuscreen(R) Online(Tm) for THC(50/100)(100TEST KTLAT · Traditional | Roche Diagnostic Systems, Inc. | 09/25/1991SE |
| K913865 | Urine THC Direct Ria Kit (I-125)LAT · Traditional | Immunalysis Corporation | 09/18/1991SE |
| K912574 | Abuscreen Online for THC (50 and 100)LAT · Traditional | Roche Diagnostic Systems, Inc. | 08/12/1991SE |
| K904996 | Abuscreen Online TM for THCLAT · Traditional | Roche Diagnostic Systems, Inc. | 01/11/1991SE |
| K843534 | Oral Thc-Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 10/30/1984SE |
| K833911 | Urine THC Cannabinoids Direct Ria KitLAT · Traditional | Immunalysis Corporation | 01/24/1984SE |
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Questions and answers
When was THC Direct Ria Kit cleared by the FDA?
THC Direct Ria Kit (K781048) received a 510(k) decision of Substantially Equivalent on October 3, 1978, 104 days after the submission was received.
What is the product code of K781048?
The FDA product code is LAT – Radioimmunoassay, Cannabinoid(S), a Class II (moderate risk) device regulated under 21 CFR 862.3870.