GGTP Reagent/Serum Iron/Salicylate Demand Analyzer
FDA 510(k) K852027 · Advanced Biomedical Methods, Inc.
510(k) numberK852027
Submission
- Device name
- GGTP Reagent/Serum Iron/Salicylate Demand Analyzer
- Applicant
- Advanced Biomedical Methods, Inc.
Niles, IL, US - Received
- May 8, 1985
- Decision date
- May 29, 1985
- 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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| K951290 | Axsym SalicylateDKJ · Traditional | Abbott Laboratories | 08/08/1995SE |
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|---|---|---|
| K945353 | Clarit(Tm)JKA · Traditional | 12/09/1994SE |
| K880949 | Single Reagent Calcium for Demand AnalyzerCJY · Traditional | 04/05/1988SE |
| K864866 | Resubmission of the Kleerzit ReagentJKA · Traditional | 03/16/1987SE |
| K852784 | Alkaline PhosphataseCJE · Traditional | 07/22/1985SE |
| K852783 | Sgot/Alt ReagentCIT · Traditional | 07/22/1985SE |
| K850381 | Magnesium Reagent for Demand AnalyzerJGJ · Traditional | 03/01/1985SE |
| K850380 | Inorganic Phosphorous for Demand AnalyzerCEO · Traditional | 03/01/1985SE |
| K850379 | Direct Bilirubin for Demand AnalyzerCIG · Traditional | 03/01/1985SE |
| K850378 | LDH Reagent for Demand AnalyzerCFJ · Traditional | 03/01/1985SE |
| K844332 | Creatinine Reagent for Demand AnalyzerCGX · Traditional | 01/03/1985SE |
Questions and answers
When was GGTP Reagent/Serum Iron/Salicylate Demand Analyzer cleared by the FDA?
GGTP Reagent/Serum Iron/Salicylate Demand Analyzer (K852027) received a 510(k) decision of Substantially Equivalent on May 29, 1985, 21 days after the submission was received.
What is the product code of K852027?
The FDA product code is DKJ – Colorimetry, Salicylate, a Class II (moderate risk) device regulated under 21 CFR 862.3830.