FDA product code KTQ: Reagent, Complement
KTQ is the FDA product code for reagent, complement. It is a Class I device, regulated under 21 CFR 866.4100 and reviewed by the Immunology panel. FDA has cleared 6 510(k) submissions under KTQ, from 4 different applicants. The average 510(k) review took 26 days (median 22).
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Complement |
| Device class | Class I |
| Regulation | 21 CFR 866.4100 |
| Review panel | IM — Immunology |
| Medical specialty | Immunology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every KTQ clearance
Top KTQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dutchland Laboratories, Inc. | 3 | 1981-09-23 |
| Atlantic Antibodies | 1 | 1989-02-17 |
| Calbiochem-Behring Corp. | 1 | 1979-08-03 |
| Cederlane Labs , Ltd. | 1 | 1979-03-21 |
Most recent KTQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K890417 | Atlantic Antibodies | SPQ(TM) ANTIBODY REAGENT SET II FOR C3 | 1989-02-17 | 24 |
| K812522 | Dutchland Laboratories, Inc. | RABBIT COMPLEMENT | 1981-09-23 | 21 |
| K812370 | Dutchland Laboratories, Inc. | GUINEA PIG COMPLEMENT REGULAR | 1981-09-08 | 19 |
| K812369 | Dutchland Laboratories, Inc. | GUINEA PIG COMPLEMENT VIRUS ANTIBODY | 1981-09-08 | 19 |
| K791117 | Calbiochem-Behring Corp. | RABBIT COMPLEMENT | 1979-08-03 | 49 |
Recalls for KTQ devices
openFDA lists no recalls for product code KTQ.
Frequently asked questions
What is FDA product code KTQ?
KTQ is the FDA product code for reagent, complement. It is a Class I device, regulated under 21 CFR 866.4100 and reviewed by the Immunology panel.
What device class is KTQ?
Class I, regulation 21 CFR 866.4100. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code KTQ?
Across 6 cleared submissions the average was 26 days from receipt to decision (median 22).
Which companies have the most KTQ clearances?
Dutchland Laboratories, Inc. (3); Atlantic Antibodies (1); Calbiochem-Behring Corp. (1); Cederlane Labs , Ltd. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code KTQ
- Run a recall and safety report across every KTQ manufacturer
- Watch product code KTQ 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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