Dimension Lithium (Li) Flex Reagent Cartridge, Model DF 132
FDA 510(k) K011033 · Dade Behring, Inc.
510(k) numberK011033
Submission
- Device name
- Dimension Lithium (Li) Flex Reagent Cartridge, Model DF 132
- Applicant
- Dade Behring, Inc.
Newark, DE, US - Received
- April 5, 2001
- Decision date
- June 7, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JIH – Flame Photometry, Lithium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.3560
- Specialty
- Clinical Toxicology
Other 510(k)s with product code JIH
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K050338 | Modification to: Instaread Lithium SystemJIH · Special | Akers Biosciences, Inc. | 03/04/2005SE |
| K031579 | Instaread Lithium SystemJIH · Traditional | Akers Laboratories, Inc. | 12/19/2003SE |
| K934106 | Kodak Ektachem DTSC II Slides (Li)JIH · Traditional | Eastman Kodak Company | 04/25/1994SE |
| K924488 | Kodak Ektachem Clinical Chemistry Slides (Li)JIH · Traditional | Eastman Kodak Company | 01/26/1993SE |
| K921403 | Model 654 AnalyzerJIH · Traditional | Ciba Corning Diagnostics Corp. | 07/30/1992SE |
| K895465 | Amdev Lytening 2Z Sodium/Potassium/Lithium AnalyzeJIH · Traditional | Baxter Healthcare Corp | 12/27/1989SE |
| K894328 | Tdx(R) Lites(Tm) LithiumJIH · Traditional | Abbott Laboratories | 11/13/1989SE |
| K830636 | Potassium DiluentJIH · Traditional | Shaban Mfg. Co. | 04/05/1983SE |
| K800039 | Lithium Diluent (1500 Mm/E)JIH · Traditional | Gilford Diagnostics | 01/21/1980SE |
| K771303 | Flame Photometer Model 460JIH · Traditional | Corning Medical & Scientific | 08/22/1977SE |
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Questions and answers
When was Dimension Lithium (Li) Flex Reagent Cartridge, Model DF 132 cleared by the FDA?
Dimension Lithium (Li) Flex Reagent Cartridge, Model DF 132 (K011033) received a 510(k) decision of Substantially Equivalent on June 7, 2001, 63 days after the submission was received.
What is the product code of K011033?
The FDA product code is JIH – Flame Photometry, Lithium, a Class II (moderate risk) device regulated under 21 CFR 862.3560.