Elvi 655 Flame Photometer
FDA 510(k) K843375 · Logos Scientific, Inc.
510(k) numberK843375
Submission
- Device name
- Elvi 655 Flame Photometer
- Applicant
- Logos Scientific, Inc.
Mchenry, IL, US - Received
- August 28, 1984
- Decision date
- May 20, 1985
- 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 |
| K841847 | Lithium ReagentJJO · Traditional | Reagent Laboratory, Inc. | 08/17/1984SE |
| K834226 | Flame PhotometersJJO · Traditional | Dr. Bruno Lange GmbH | 06/22/1984SE |
| 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.
| 510(k) | Device | Decision |
|---|---|---|
| K902614 | Elvi 828 Digiclot MultiscanKQG · Traditional | 11/08/1990SE |
| K844710 | Eurochima Serum Protein Electrophoresis MethodJJN · Traditional | 01/07/1985SE |
| K843296 | Elvi 675 DigitronJJQ · Traditional | 09/13/1984SE |
| K842313 | Elvi 146 SeroscanJQT · Traditional | 09/10/1984SE |
| K842056 | Elvi 165 Proteo SeroskopJQT · Traditional | 06/22/1984SE |
| K841804 | Elvi 70 Safety ChamberJJN · Traditional | 05/31/1984SE |
| K840757 | Elvi 444 BilitronCIG · Traditional | 05/30/1984SE |
| K841288 | Elvi 18JJN · Traditional | 05/02/1984SE |
Questions and answers
When was Elvi 655 Flame Photometer cleared by the FDA?
Elvi 655 Flame Photometer (K843375) received a 510(k) decision of Substantially Equivalent on May 20, 1985, 265 days after the submission was received.
What is the product code of K843375?
The FDA product code is JJO – Flame Emission Photometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2540.