Lytetek System
FDA 510(k) K770774 · Boehringer Mannheim Corp.
510(k) numberK770774
Submission
- Device name
- Lytetek System
- Applicant
- Boehringer Mannheim Corp.
Mchenry, IL, US - Received
- April 28, 1977
- Decision date
- July 11, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JGT – Flame Photometry, Sodium
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 862.1665
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JGT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K896829 | Technicon Ra Systems Sodium (Colorimetric Method)JGT · Traditional | Technicon Instruments Corp. | 02/23/1990SE |
| K891574 | Lithium Concentrate #SR1031, Na/K Standards SR1030JGT · Traditional | Em Diagnostic Systems, Inc. | 06/09/1989SE |
| K841610 | Components for Potassium, Sodium ChloJGT · Traditional | Shaban Mfg. Co. | 05/25/1984SE |
| K840216 | Sodium/Potassium Reagent SysJGT · Traditional | Sclavo, Inc. | 03/19/1984SE |
| K834248 | Parallel Flame Photometer & SodiumJGT · Traditional | American Monitor Corp. | 01/30/1984SE |
| K811886 | Cesium Diluent 7.5MJGT · Traditional | Gilford Diagnostics | 07/23/1981SE |
| K801892 | Klinar Reagent Pak, #36010JGT · Traditional | Hi Chem, Inc. | 10/23/1980SE |
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| K984372 | Elecsys Calcheck Troponin TJJY · Traditional | 12/14/1998SE |
| K984105 | Elecsys Troponin T Stat TestMMI · Traditional | 12/08/1998SE |
| K983503 | Roche Diagnostics, Boehringer Mannheim Corporation Inorganic Phosphorus Reagent Catalog…CEO · Traditional | 12/01/1998SE |
| K983469 | Preciset Serum Proteins CalibratorJIX · Traditional | 11/25/1998SE |
| K983185 | Boehringer Mannheim Tina-Quant Ige TestDGC · Traditional | 11/12/1998SE |
| K983510 | Chemstrip 101 Urine AnalyzerKQO · Special | 10/27/1998SE |
Questions and answers
When was Lytetek System cleared by the FDA?
Lytetek System (K770774) received a 510(k) decision of Substantially Equivalent on July 11, 1977, 74 days after the submission was received.
What is the product code of K770774?
The FDA product code is JGT – Flame Photometry, Sodium, a Class II (moderate risk) device regulated under 21 CFR 862.1665.