FDA product code JCC: Ph Buffer
JCC is the FDA product code for ph buffer. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel. FDA has cleared 7 510(k) submissions under JCC, from 6 different applicants. The average 510(k) review took 44 days (median 47). FDA has posted 2 recalls for JCC devices.
Classification
| Field | Value |
|---|---|
| Device name | Ph Buffer |
| Device class | Class I |
| Regulation | 21 CFR 864.4010 |
| Review panel | PA — Pathology |
| Medical specialty | Pathology |
| Premarket route | 510(k) exempt |
| GMP exempt | Yes |
Compare with all 510(k) review times · Search every JCC clearance
Top JCC applicants
| Applicant | Clearances | Latest |
|---|---|---|
| E K Ind., Inc. | 2 | 1984-09-11 |
| Reagent Laboratory, Inc. | 1 | 1984-05-22 |
| Dutchland Laboratories, Inc. | 1 | 1981-08-25 |
| Bioscientific | 1 | 1981-05-21 |
| Electrophoresis Corp. of America | 1 | 1980-01-21 |
1 more applicants have JCC clearances. See the full list in Caduvo.
Most recent JCC clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K842918 | E K Ind., Inc. | SCOTTS TAP WATER SUBSTITUTE | 1984-09-11 | 48 |
| K842914 | E K Ind., Inc. | WRIGHT STAIN BUFFER | 1984-09-07 | 44 |
| K841423 | Reagent Laboratory, Inc. | SCOTTS TAP WATER SUBSTITUTE 7 | 1984-05-22 | 47 |
| K811791 | Dutchland Laboratories, Inc. | PHOSPHATE BUFFERED SALINE (1X) | 1981-08-25 | 62 |
| K811251 | Bioscientific | CITRATE BUFFER | 1981-05-21 | 16 |
Recalls for JCC devices
2 product recalls in 2 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2013-09-13.
Frequently asked questions
What is FDA product code JCC?
JCC is the FDA product code for ph buffer. It is a Class I device, regulated under 21 CFR 864.4010 and reviewed by the Pathology panel.
What device class is JCC?
Class I, regulation 21 CFR 864.4010. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code JCC?
Across 7 cleared submissions the average was 44 days from receipt to decision (median 47).
Which companies have the most JCC clearances?
E K Ind., Inc. (2); Reagent Laboratory, Inc. (1); Dutchland Laboratories, Inc. (1); Bioscientific (1); Electrophoresis Corp. of America (1).
Have JCC devices been recalled?
Yes: 2 product recalls across 2 recall events; the most recent began 2013-09-13.
Next steps
- Run an FDA pathway report with predicate devices for product code JCC
- Run a recall and safety report across every JCC manufacturer
- Watch product code JCC for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Pathology product codes · FDA product code lookup · 510(k) database search · 510(k) review times