I.L. Model 643 Flame Photometer
FDA 510(k) K771337 · Instrumentation Laboratory CO
510(k) numberK771337
Submission
- Device name
- I.L. Model 643 Flame Photometer
- Applicant
- Instrumentation Laboratory CO
Mchenry, IL, US - Received
- July 19, 1977
- Decision date
- October 18, 1977
- 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 |
| 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 |
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Questions and answers
When was I.L. Model 643 Flame Photometer cleared by the FDA?
I.L. Model 643 Flame Photometer (K771337) received a 510(k) decision of Substantially Equivalent on October 18, 1977, 91 days after the submission was received.
What is the product code of K771337?
The FDA product code is JJO – Flame Emission Photometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2540.