Lkb Instruments, Inc.: FDA clearances and approvals
Lkb Instruments, Inc. has 52 FDA 510(k) clearances (first 1976, latest 1987), across 35 product codes in 8 review panels. Median 510(k) review time: 45 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JJQ | Colorimeter, Photometer, Spectrophotometer For Clinical Use | 7 | 7 |
| JJJ | Counter (Beta, Gamma) For Clinical Use | 5 | 5 |
| IDO | Microtome, Rotary | 3 | 3 |
| JQC | Centrifuges (Micro, Ultra, Refrigerated) For Clinical Use | 3 | 3 |
| JJF | Analyzer, Chemistry, Micro, For Clinical Use | 2 | 2 |
| JLW | Radioimmunoassay, Thyroid-Stimulating Hormone | 2 | 2 |
| KHO | Fluorometer, For Clinical Use | 2 | 2 |
| BYD | Condenser, Heat And Moisture (Artificial Nose) | 1 | 1 |
| BZL | Computer, Oxygen-Uptake | 1 | 1 |
| CBD | Bottle, Collection, Breathing System (Calibrated) | 1 | 1 |
Plus 25 more product codes.
Review panels
- Clinical Chemistry (34)
- Anesthesiology (5)
- Pathology (5)
- Clinical Toxicology (4)
- Cardiovascular (1)
- General Hospital (1)
- Immunology (1)
- Microbiology (1)
Most recent Lkb Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | JJJ | 1987-11-04 | 35 |
| K872955 | DELFIA(TM) FERRITIN KIT | JMG | 1987-08-21 | 23 |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | CDX | 1987-06-17 | 77 |
| K871599 | DELFIA(TM) HIGE KIT | DHB | 1987-06-12 | 49 |
| K871644 | DELFIA (TM) HTSH KIT | JLW | 1987-05-12 | 15 |
| K864452 | DELFIA(TM) TRIIODOTHYRONINE (T3) KIT | CDP | 1987-02-02 | 82 |
| K864733 | LKB 2260 MACROTOME | IDO | 1987-01-05 | 32 |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | GWC | 1986-12-18 | 142 |
| K863422 | DELFIA(TM) CORTISOL KIT | JFT | 1986-09-26 | 22 |
| K862044 | DELFIA (TM) HCG KIT | JHJ | 1986-07-11 | 44 |
42 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Lkb Instruments, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Lkb Instruments, Inc. have?
Lkb Instruments, Inc. has 52 FDA 510(k) clearances (first 1976, latest 1987), across 35 product codes in 8 review panels.
How long does FDA take to clear Lkb Instruments, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Lkb Instruments, Inc.'s cleared 510(k)s is 45 days.
What devices does Lkb Instruments, Inc. make?
Its most frequent FDA product codes are JJQ (Colorimeter, Photometer, Spectrophotometer For Clinical Use, 7); JJJ (Counter (Beta, Gamma) For Clinical Use, 5); IDO (Microtome, Rotary, 3).
Has Lkb Instruments, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Lkb Instruments, Inc. Related entities may recall under other names.
Next steps
- See all 52 Lkb Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JJQ, Lkb Instruments, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.