Rapid Chem Analyzer II
FDA 510(k) K830095 · Macomb Chemical Co.
510(k) numberK830095
Submission
- Device name
- Rapid Chem Analyzer II
- Applicant
- Macomb Chemical Co.
Mchenry, IL, US - Received
- January 11, 1983
- Decision date
- January 28, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJF – Analyzer, Chemistry, Micro, For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2170
- Specialty
- Clinical Chemistry
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| K993634 | Careside AnalyzerJJF · Traditional | Careside, Inc. | 12/02/1999SE |
| K973628 | Vitalab Flexor/Vitalab Selectra 2/VITALAB VivaJJF · Traditional | Vital Scientific N.V. | 03/13/1998SE |
| K980056 | Careside AnalyzerJJF · Traditional | Exigent Diagnostics, Inc. | 03/06/1998SE |
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More from Synermed, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K823720 | SpectrophotometerJJQ · Traditional | 01/07/1983SE |
| K810958 | GlycohemoglobinLCP · Traditional | 09/16/1981SE |
| K801086 | P-Nitrophenyl Phosphate · Traditional | 05/28/1980SE |
| K800719 | Enzymatic Urea Nitrogen Reagent Set ReviCDQ · Traditional | 05/08/1980SE |
| K800720 | Macomb Nad-Nicotinamide Adenine Dinucleo · Traditional | 04/21/1980SE |
| K792533 | Creatine Phosphokinase (CPK) Reagent SetJHW · Traditional | 01/11/1980SE |
| K792532 | Glucose (Hexokinase) Reagent SetCFR · Traditional | 01/11/1980SE |
| K791669 | Glucose Oxidase Reagent SetCGA · Traditional | 09/24/1979SE |
| K791511 | Enzymatic Reagent Set, 4X250 Ml.CHH · Traditional | 09/04/1979SE |
| K791119 | Macomb Normal Control SerumJJY · Traditional | 07/30/1979SE |
Questions and answers
When was Rapid Chem Analyzer II cleared by the FDA?
Rapid Chem Analyzer II (K830095) received a 510(k) decision of Substantially Equivalent on January 28, 1983, 17 days after the submission was received.
What is the product code of K830095?
The FDA product code is JJF – Analyzer, Chemistry, Micro, For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2170.