Flame Photometers
FDA 510(k) K834226 · Dr. Bruno Lange GmbH
510(k) numberK834226
Submission
- Device name
- Flame Photometers
- Applicant
- Dr. Bruno Lange GmbH
Walker, MI, US - Received
- December 6, 1983
- Decision date
- June 22, 1984
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- JJO – Flame Emission Photometer For Clinical Use
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 862.2540
- Specialty
- Clinical Chemistry
Other 510(k)s with product code JJO
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K873603 | Finnigan Mat Incos 50JJO · Traditional | Finnigan Corp. | 09/22/1987SE |
| K862148 | Olympus Au 5000 Flame Photometer ModuleJJO · Traditional | Olympus Corp. | 09/29/1986SE |
| K843375 | Elvi 655 Flame PhotometerJJO · Traditional | Logos Scientific, Inc. | 05/20/1985SE |
| K841847 | Lithium ReagentJJO · Traditional | Reagent Laboratory, Inc. | 08/17/1984SE |
| K841422 | Volume Test Dye 6JJO · Traditional | Reagent Laboratory, Inc. | 05/11/1984SE |
| K841421 | Daily Wash Solution 5JJO · Traditional | Reagent Laboratory, Inc. | 05/11/1984SE |
| K840530 | Supplies for Instrumentation Lab FlameJJO · Traditional | Shaban Mfg. Co. | 03/30/1984SE |
| K840044 | Sdi Prepax Dilukit 29-1000JJO · Traditional | Scientific Distributors, Inc. | 03/09/1984SE |
| K833535 | Potassium Sodium Analysis ProductsJJO · Traditional | Shaban Mfg. Co. | 12/29/1983SE |
| K832886 | Flame Photometer T281-T282-T283JJO · Traditional | Texas Intl. Laboratories, Inc. | 12/08/1983SE |
More from Texas Intl. Laboratories, Inc.
Questions and answers
When was Flame Photometers cleared by the FDA?
Flame Photometers (K834226) received a 510(k) decision of Substantially Equivalent on June 22, 1984, 199 days after the submission was received.
What is the product code of K834226?
The FDA product code is JJO – Flame Emission Photometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2540.