Product code JCC
- Device name
- Ph Buffer
- Medical specialty
- Pathology
- Device class
- 1
- Regulation number
- 864.4010
- Review panel
- PA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- Y
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K842918 | SCOTTS TAP WATER SUBSTITUTE | E K Ind., Inc. | 1984-09-11 |
| K842914 | WRIGHT STAIN BUFFER | E K Ind., Inc. | 1984-09-07 |
| K841423 | SCOTTS TAP WATER SUBSTITUTE 7 | Reagent Laboratory, Inc. | 1984-05-22 |
| K811791 | PHOSPHATE BUFFERED SALINE (1X) | Dutchland Laboratories, Inc. | 1981-08-25 |
| K811251 | CITRATE BUFFER | Bioscientific | 1981-05-21 |
| K792574 | MOPSO BUFFER | Electrophoresis Corp. of America | 1980-01-21 |
| K770508 | SMAC SYSTEM | Mid Tech, Inc. | 1977-05-09 |
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| 00846405022335 | Diagnostic BioSystems | Diagnostic Biosystems, Inc. | 2026-06-08 |
| 00846405022328 | Diagnostic BioSystems | Diagnostic Biosystems, Inc. | 2026-06-08 |
| 00846405022311 | Diagnostic BioSystems | Diagnostic Biosystems, Inc. | 2026-06-08 |
| 00846405022304 | Diagnostic BioSystems | Diagnostic Biosystems, Inc. | 2026-06-08 |
| 00846405022298 | Diagnostic BioSystems | Diagnostic Biosystems, Inc. | 2026-06-08 |
| 00846405017355 | Diagnostic BioSystems | Diagnostic Biosystems, Inc. | 2026-06-08 |
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| 00846405023295 | Diagnostic BioSystems | Diagnostic Biosystems, Inc. | 2026-06-04 |
| 00380740136994 | Alinity | ABBOTT LABORATORIES | 2023-11-16 |
| M9850200300 | MesaLabs | MESA LABORATORIES, INC. | 2015-07-02 |
| M9850200310 | MesaLabs | MESA LABORATORIES, INC. | 2015-07-02 |