FDA product code CJA: Amyloclastic, Amylase
CJA is the FDA product code for amyloclastic, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel. FDA has cleared 10 510(k) submissions under CJA, from 10 different applicants. The average 510(k) review took 53 days (median 52).
Classification
| Field | Value |
|---|---|
| Device name | Amyloclastic, Amylase |
| Device class | Class II |
| Regulation | 21 CFR 862.1070 |
| Review panel | CH — Clinical Chemistry |
| Medical specialty | Clinical Chemistry |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
Compare with all 510(k) review times · Search every CJA clearance
Top CJA applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Hichem Diagnostics | 1 | 1989-12-22 |
| A-Kem, Inc. | 1 | 1988-12-09 |
| Wako Chemicals USA, Inc. | 1 | 1988-08-30 |
| Baxter Healthcare Corp | 1 | 1987-11-23 |
| J. D. Assoc. | 1 | 1986-09-09 |
5 more applicants have CJA clearances. See the full list in Caduvo.
Most recent CJA clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K895555 | Hichem Diagnostics | MODIFIED HI CHEM AMYLASE REAGENT (PRODUCT #88129) | 1989-12-22 | 107 |
| K884226 | A-Kem, Inc. | AMYLASE REAGENT KIT FOR ASTRA SYSTEMS | 1988-12-09 | 64 |
| K883059 | Wako Chemicals USA, Inc. | WAKO(TM) AUTOKIT AMYLASE | 1988-08-30 | 42 |
| K873520 | Baxter Healthcare Corp | PARAMAX AMYLASE REAGENT | 1987-11-23 | 83 |
| K863052 | J. D. Assoc. | ALPHA AMYLASE | 1986-09-09 | 28 |
Recalls for CJA devices
openFDA lists no recalls for product code CJA.
Frequently asked questions
What is FDA product code CJA?
CJA is the FDA product code for amyloclastic, amylase. It is a Class II device, regulated under 21 CFR 862.1070 and reviewed by the Clinical Chemistry panel.
What device class is CJA?
Class II, regulation 21 CFR 862.1070. Typical premarket route: 510(k).
How long does a 510(k) take for product code CJA?
Across 10 cleared submissions the average was 53 days from receipt to decision (median 52).
Which companies have the most CJA clearances?
Hichem Diagnostics (1); A-Kem, Inc. (1); Wako Chemicals USA, Inc. (1); Baxter Healthcare Corp (1); J. D. Assoc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code CJA
- Run a recall and safety report across every CJA manufacturer
- Watch product code CJA 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.
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