Citrate Buffer
FDA 510(k) K811251 · Bioscientific
510(k) numberK811251
Submission
- Device name
- Citrate Buffer
- Applicant
- Bioscientific
Mchenry, IL, US - Received
- May 5, 1981
- Decision date
- May 21, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code JCC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K842918 | Scotts Tap Water SubstituteJCC · Traditional | E K Ind., Inc. | 09/11/1984SE |
| K842914 | Wright Stain BufferJCC · Traditional | E K Ind., Inc. | 09/07/1984SE |
| K841423 | Scotts Tap Water Substitute 7JCC · Traditional | Reagent Laboratory, Inc. | 05/22/1984SE |
| K811791 | Phosphate Buffered Saline (1X)JCC · Traditional | Dutchland Laboratories, Inc. | 08/25/1981SE |
| K792574 | Mopso BufferJCC · Traditional | Electrophoresis Corp. of America | 01/21/1980SE |
| K770508 | Smac SystemJCC · Traditional | Mid Tech, Inc. | 05/09/1977SE |
More from Mid Tech, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K812447 | Amylase Reagent KitKHM · Traditional | 09/09/1981SE |
| K801268 | Hemoglobin Control LevelsKHG · Traditional | 07/14/1980SE |
| K801267 | Red Blood Cell Count & Hematocrit CNTLJPK · Traditional | 07/14/1980SE |
| K801265 | White Blood Cell Count Control LevelsJPK · Traditional | 07/14/1980SE |
| K791658 | Wright Stain Pack · Traditional | 10/17/1979SE |
| K791007 | Stat Diff StainKQC · Traditional | 08/03/1979SE |
| K790415 | HCP-7JPK · Traditional | 04/04/1979SE |
| K781734 | Sodium Chloride, 0.85% · Traditional | 10/24/1978SE |
| K781588 | Papanicolaou Stian OG-6HZJ · Traditional | 10/10/1978SE |
| K781587 | Hematology Stain PackIAF · Traditional | 10/10/1978SE |
Questions and answers
When was Citrate Buffer cleared by the FDA?
Citrate Buffer (K811251) received a 510(k) decision of Substantially Equivalent on May 21, 1981, 16 days after the submission was received.
What is the product code of K811251?
The FDA product code is JCC – Ph Buffer, a Class I (low risk) device regulated under 21 CFR 864.4010.