Toxi-Lab Rapid Screen
FDA 510(k) K823523 · Marion Laboratories, Inc.
510(k) numberK823523
Submission
- Device name
- Toxi-Lab Rapid Screen
- Applicant
- Marion Laboratories, Inc.
Walker, MI, US - Received
- November 29, 1982
- Decision date
- January 14, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DKJ – Colorimetry, Salicylate
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3830
- Specialty
- Clinical Toxicology
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| K981872 | Salicylate-Sl Assay Catalogue Number 511-20,511-40DKJ · Traditional | Diagnostic Chemicals , Ltd. | 06/29/1998SE |
| K980032 | Salicylate Assay (Ace), Catalogue Number 501-71DKJ · Traditional | Diagnostic Chemicals , Ltd. | 03/02/1998SE |
| K964715 | Paramax Salicylate ReagentDKJ · Traditional | Dade Intl., Inc. | 04/25/1997SE |
| K961131 | Salicylate AssayDKJ · Traditional | Diagnostic Reagents, Inc. | 04/29/1996SE |
| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
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|---|---|---|
| K883391 | Polymer Adhesive BandageNAD · Traditional | 03/23/1989SN |
| K875182 | Modified Labeling for Toxi-Lab THC ScreenDKE · Traditional | 07/05/1988SE |
| K875181 | Modified Labeling for Toxi-Lab Broad Spectrum · Traditional | 05/27/1988SE |
| K874554 | Enviclusive (TM)NAD · Traditional | 03/11/1988SE |
| K874552 | Envisan PadKOZ · Traditional | 01/22/1988SN |
| K874551 | Envinet(Tm)EFQ · Traditional | 01/22/1988SN |
| K874553 | Envisan PasteKOZ · Traditional | 12/18/1987SN |
| K870864 | Culturette Brand CDT Clostridium Difficile TestLLH · Traditional | 04/14/1987SE |
| K863485 | Modification of Cdt(Tm) Clostridium TestLLH · Traditional | 09/17/1986SE |
| K862123 | Biosphere Anaerobic Environmental DeviceKZJ · Traditional | 06/16/1986SE |
Questions and answers
When was Toxi-Lab Rapid Screen cleared by the FDA?
Toxi-Lab Rapid Screen (K823523) received a 510(k) decision of Substantially Equivalent on January 14, 1983, 46 days after the submission was received.
What is the product code of K823523?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.