Cobas FP Reagen for Primidone & Primi Calibrators
FDA 510(k) K852318 · Roche Diagnostic Systems, Inc.
510(k) numberK852318
Submission
- Device name
- Cobas FP Reagen for Primidone & Primi Calibrators
- Applicant
- Roche Diagnostic Systems, Inc.
Nutley, NJ, US - Received
- May 31, 1985
- Decision date
- June 25, 1985
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LFT – Fluorescent Immunoassay, Primidone
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3680
- Specialty
- Clinical Toxicology
Other 510(k)s with product code LFT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K950028 | Primidone Fpia Reagent Set and CalibratorsLFT · Traditional | Sigma Diagnostics, Inc. | 03/21/1995SE |
| K904683 | Stratus Primidone Fluorometric EnzymeLFT · Traditional | Baxter Healthcare Corp | 11/28/1990SE |
| K895567 | Primidone (Fpia) KitLFT · Traditional | Tudor Laboratories, Inc. | 10/20/1989SE |
| K842196 | Stratus Primidone Florometric EnzyLFT · Traditional | American Dade | 07/11/1984SE |
| K823741 | Advance Emit-Aed Primedone AssayLFT · Traditional | Syva Co. | 01/07/1983SE |
| K822229 | Primidone Fluorescent ImmunoassayLFT · Traditional | American Diagnostic Corp. | 08/12/1982SE |
| K811007 | Ames Tda TM Primidone TestLFT · Traditional | Miles Laboratories, Inc. | 04/29/1981SE |
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| K983704 | Modification to Abuscreen Online for PhencyclidineJCM · Traditional | 02/10/1999SE |
| K983556 | Abuscreen Online Benz 300 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983555 | Abuscreen Online Benz 200 CalibratorsDLJ · Traditional | 12/15/1998SE |
| K983703 | Modification to Abuscreen Online for MethadoneDJR · Special | 12/11/1998SE |
| K983701 | Modification to Abuscreen Online for CannabinoidsLDJ · Special | 12/11/1998SE |
| K983700 | Modification to Abuscreen Online for PropoxypheneJXN · Special | 12/11/1998SE |
| K983699 | Modification to Abuscreen Online for AmphetaminesDKZ · Special | 12/11/1998SE |
| K983697 | Modification to Abuscreen Online Cocaine MetaboliteDIO · Special | 12/11/1998SE |
Questions and answers
When was Cobas FP Reagen for Primidone & Primi Calibrators cleared by the FDA?
Cobas FP Reagen for Primidone & Primi Calibrators (K852318) received a 510(k) decision of Substantially Equivalent on June 25, 1985, 25 days after the submission was received.
What is the product code of K852318?
The FDA product code is LFT – Fluorescent Immunoassay, Primidone, a Class II (moderate risk) device regulated under 21 CFR 862.3680.