Ph Buffer
A pH buffer is a laboratory reagent solution used in pathology and clinical chemistry settings to maintain a stable and known pH environment for reagent systems, instrument calibration, and specimen processing. It is classified as FDA Class 1, the lowest risk category, and is exempt from Good Manufacturing Practice requirements and premarket notification. The product code is JCC, regulated under 21 CFR 864.4010, within the Pathology medical specialty. This device is GMP exempt.
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Basic Information
- Product Code
- JCC
- Device Class
- FDA class 1
- Regulation Number
- 864.4010
- Medical Specialty
- Pathology
- Review Panel
- PA
- Submission Type
- 4
Device Characteristics
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 7 510(k) clearances via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K842918 | SCOTTS TAP WATER SUBSTITUTE | Sep 11, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K842914 | WRIGHT STAIN BUFFER | Sep 07, 1984 | Substantially Equivalent | E K Ind., Inc. |
| K841423 | SCOTTS TAP WATER SUBSTITUTE 7 | May 22, 1984 | Substantially Equivalent | Reagent Laboratory, Inc. |
| K811791 | PHOSPHATE BUFFERED SALINE (1X) | Aug 25, 1981 | Substantially Equivalent | Dutchland Laboratories, Inc. |
| K811251 | CITRATE BUFFER | May 21, 1981 | Substantially Equivalent | Bioscientific |
| K792574 | MOPSO BUFFER | Jan 21, 1980 | Substantially Equivalent | Electrophoresis Corp. of America |
| K770508 | SMAC SYSTEM | May 09, 1977 | Substantially Equivalent | Mid Tech, Inc. |
FEI Numbers
This FDA classification entry is associated with 46 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 46 registration numbers. Click on an entry to view related FDA registrations.