Salicylate Assay (Ace), Catalogue Number 501-71
FDA 510(k) K980032 · Diagnostic Chemicals , Ltd.
510(k) numberK980032
Submission
- Device name
- Salicylate Assay (Ace), Catalogue Number 501-71
- Applicant
- Diagnostic Chemicals , Ltd.
Charlottetown, P.E.I., CA - Received
- January 5, 1998
- Decision date
- March 2, 1998
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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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| K020794 | Salicylate Assay for the Advia Integrated Modular SystemDKJ · Traditional | Bayer Diagnostics Corp. | 07/11/2002SE |
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| K981872 | Salicylate-Sl Assay Catalogue Number 511-20,511-40DKJ · Traditional | Diagnostic Chemicals , Ltd. | 06/29/1998SE |
| 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 |
| K946000 | Abuscreen Online(R) CalibratorsDKJ · Traditional | Roche Diagnostic Systems, Inc. | 01/25/1995SE |
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Questions and answers
When was Salicylate Assay (Ace), Catalogue Number 501-71 cleared by the FDA?
Salicylate Assay (Ace), Catalogue Number 501-71 (K980032) received a 510(k) decision of Substantially Equivalent on March 2, 1998, 56 days after the submission was received.
What is the product code of K980032?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.