FDA product code LSQ: Reagent, Rickettsia Serological
LSQ is the FDA product code for reagent, rickettsia serological. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel. FDA has cleared 4 510(k) submissions under LSQ, from 3 different applicants. The average 510(k) review took 256 days (median 288).
Classification
| Field | Value |
|---|---|
| Device name | Reagent, Rickettsia Serological |
| Device class | Class I |
| Regulation | 21 CFR 866.3500 |
| Review panel | MI — Microbiology |
| Medical specialty | Microbiology |
| Premarket route | 510(k) exempt |
Compare with all 510(k) review times · Search every LSQ clearance
Top LSQ applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Intercare Diagnostics, Inc. | 2 | 1993-02-09 |
| David C. Bishop, Ph.D. | 1 | 1998-03-13 |
| Health Research, Inc. | 1 | 1987-08-19 |
Most recent LSQ clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K971591 | David C. Bishop, Ph.D. | INDX DIP-S-TICKS SCRUB TYPHUS TEST FOR THE DETECTION OF IGG AND IGM ANTIBODIES TO ORIENTIA TSUTSUGAMUSHI (SCRUB TYPHUS) | 1998-03-13 | 316 |
| K920569 | Intercare Diagnostics, Inc. | INDXTM DIP-S-TICKSTM | 1993-02-09 | 368 |
| K901597 | Intercare Diagnostics, Inc. | INDX DIP S TICKS | 1990-12-21 | 260 |
| K872129 | Health Research, Inc. | LATEX R. CONORII | 1987-08-19 | 78 |
Recalls for LSQ devices
openFDA lists no recalls for product code LSQ.
Frequently asked questions
What is FDA product code LSQ?
LSQ is the FDA product code for reagent, rickettsia serological. It is a Class I device, regulated under 21 CFR 866.3500 and reviewed by the Microbiology panel.
What device class is LSQ?
Class I, regulation 21 CFR 866.3500. Typical premarket route: 510(k) exempt.
How long does a 510(k) take for product code LSQ?
Across 4 cleared submissions the average was 256 days from receipt to decision (median 288).
Which companies have the most LSQ clearances?
Intercare Diagnostics, Inc. (2); David C. Bishop, Ph.D. (1); Health Research, Inc. (1).
Next steps
- Run an FDA pathway report with predicate devices for product code LSQ
- Run a recall and safety report across every LSQ manufacturer
- Watch product code LSQ 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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