Daily Wash Solution 5
FDA 510(k) K841421 · Reagent Laboratory, Inc.
510(k) numberK841421
Submission
- Device name
- Daily Wash Solution 5
- Applicant
- Reagent Laboratory, Inc.
Mchenry, IL, US - Received
- April 5, 1984
- Decision date
- May 11, 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 |
| K834226 | Flame PhotometersJJO · Traditional | Dr. Bruno Lange GmbH | 06/22/1984SE |
| K841422 | Volume Test Dye 6JJO · 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 |
|---|---|---|
| K863502 | Solution B- Na 50MEQ/L, K 40 Meq/LJIX · Traditional | 10/21/1986SE |
| K863503 | HemolyseGGK · Traditional | 10/03/1986SE |
| K863550 | Potassium Hydroxide 10% W/VPPM · Traditional | 10/02/1986SE |
| K860143 | Urine Diluent-For Use with Ion Selective ElectrodeJJP · Traditional | 02/10/1986SE |
| K842982 | Formalin BufferedIFP · Traditional | 10/01/1984SE |
| K843050 | Gram StainJTS · Traditional | 09/11/1984SE |
| K842785 | Stain, Methylene Blue-EosinKFC · Traditional | 09/11/1984SE |
| K841847 | Lithium ReagentJJO · Traditional | 08/17/1984SE |
| K843051 | Wrights Stain Solution · Traditional | 08/03/1984SESP |
| K841800 | Lysing & Hemoglobin ReagentGGK · Traditional | 05/31/1984SE |
Questions and answers
When was Daily Wash Solution 5 cleared by the FDA?
Daily Wash Solution 5 (K841421) received a 510(k) decision of Substantially Equivalent on May 11, 1984, 36 days after the submission was received.
What is the product code of K841421?
The FDA product code is JJO – Flame Emission Photometer For Clinical Use, a Class I (low risk) device regulated under 21 CFR 862.2540.