JCC
7 FDA 510(k) clearances · Product code
47 daysmedian time to decision
62 days90th percentile
7clearances measured
FDA profile
- Official device name
- Ph Buffer
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 864.4010
- Medical specialty
- Pathology
- Flags
- GMP exempt
- Adverse events (MAUDE)
- 2013: 22 · 2014: 103 · 2016: 32
Reports received by FDA, not confirmed device causation - volume tracks device popularity as much as risk.
Export predicate table (CSV) Shareable report ◉ Watch exports: 3 free/month · reports & watching: free
| Record | Firm | Date |
|---|---|---|
| SCOTTS TAP WATER SUBSTITUTE (K842918) | E K Ind., Inc. | 1984-09-11 |
| WRIGHT STAIN BUFFER (K842914) | E K Ind., Inc. | 1984-09-07 |
| SCOTTS TAP WATER SUBSTITUTE 7 (K841423) | Reagent Laboratory, Inc. | 1984-05-22 |
| PHOSPHATE BUFFERED SALINE (1X) (K811791) | Dutchland Laboratories, Inc. | 1981-08-25 |
| CITRATE BUFFER (K811251) | Bioscientific | 1981-05-21 |
| MOPSO BUFFER (K792574) | Electrophoresis Corp. of America | 1980-01-21 |
| SMAC SYSTEM (K770508) | Mid Tech, Inc. | 1977-05-09 |
Track JCC automatically
Every clearance here is in the API, with alerts when new ones post.