Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lkb Instruments, Inc. — Predicate Candidate Screening
52 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
46 daysmedian FDA review time
142 days90th percentile
52clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | Lkb Instruments, Inc. | 1987-11-04 | 35 | 0 |
| K872955 | DELFIA(TM) FERRITIN KIT | Lkb Instruments, Inc. | 1987-08-21 | 23 | 0 |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | Lkb Instruments, Inc. | 1987-06-17 | 77 | 0 |
| K871599 | DELFIA(TM) HIGE KIT | Lkb Instruments, Inc. | 1987-06-12 | 49 | 0 |
| K871644 | DELFIA (TM) HTSH KIT | Lkb Instruments, Inc. | 1987-05-12 | 15 | 0 |
| K864452 | DELFIA(TM) TRIIODOTHYRONINE (T3) KIT | Lkb Instruments, Inc. | 1987-02-02 | 82 | 0 |
| K864733 | LKB 2260 MACROTOME | Lkb Instruments, Inc. | 1987-01-05 | 32 | 0 |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | Lkb Instruments, Inc. | 1986-12-18 | 142 | 0 |
| K863422 | DELFIA(TM) CORTISOL KIT | Lkb Instruments, Inc. | 1986-09-26 | 22 | 0 |
| K862044 | DELFIA (TM) HCG KIT | Lkb Instruments, Inc. | 1986-07-11 | 44 | 0 |
| K861195 | DELFIA DIGOXIN | Lkb Instruments, Inc. | 1986-07-11 | 102 | 0 |
| K862043 | DELFIA (TM) HFSH KIT | Lkb Instruments, Inc. | 1986-06-24 | 27 | 1 |
| K861542 | DELFIA (TM) HUMAN PROLACTIN | Lkb Instruments, Inc. | 1986-06-17 | 54 | 0 |
| K861194 | ULTROSPEC K KINETICS SPECTROPHOTOMETER | Lkb Instruments, Inc. | 1986-04-24 | 24 | 0 |
| K855173 | DELFIA TM HLH KIT | Lkb Instruments, Inc. | 1986-02-28 | 64 | 0 |
| K852760 | LBK 1244 DELFIA HCG KIT | Lkb Instruments, Inc. | 1985-12-05 | 160 | 0 |
| K852538 | LKB 4057 ULTROSPEC II E | Lkb Instruments, Inc. | 1985-09-30 | 144 | 0 |
| K852434 | 1208 BETACORD AND 1208 BETCORD M | Lkb Instruments, Inc. | 1985-08-02 | 53 | 0 |
| K851120 | DELFIA HTSH KIT | Lkb Instruments, Inc. | 1985-05-31 | 73 | 0 |
| K851984 | LKB-WALLAC 1230 ARCUS FLUOROMETER | Lkb Instruments, Inc. | 1985-05-24 | 17 | 0 |
| K851572 | NOVASPEC VISIBLE SPECTROPHOTOMETER | Lkb Instruments, Inc. | 1985-05-20 | 33 | 0 |
| K844413 | ULTROSER G | Lkb Instruments, Inc. | 1985-02-27 | 105 | 0 |
| K844164 | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A | Lkb Instruments, Inc. | 1984-12-10 | 46 | 0 |
| K843505 | LKB 2230 ROTARY ONE | Lkb Instruments, Inc. | 1984-11-30 | 85 | 0 |
| K843506 | LKB 2189 ULTROPROCESSOR | Lkb Instruments, Inc. | 1984-11-30 | 85 | 0 |
| K842028 | CM-TRISACRYL M DEAE-TRISACRYL M | Lkb Instruments, Inc. | 1984-06-07 | 20 | 0 |
| K834490 | GELSCAN SOFTWARE 2190 | Lkb Instruments, Inc. | 1984-05-01 | 147 | 0 |
| K840985 | TRISACRYL GF 05 & TRISACRYL GF 2000 | Lkb Instruments, Inc. | 1984-04-19 | 43 | 0 |
| K834489 | ULTROSPEC W/APPLE II -4050- | Lkb Instruments, Inc. | 1984-02-10 | 70 | 0 |
| K830797 | IMMOBILINE SYSTEM LKB 1819 | Lkb Instruments, Inc. | 1983-08-24 | 163 | 0 |
| K831942 | LKB 2164 MACRO-SPIN R CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 | 43 | 0 |
| K831947 | LKB 2160 MIDISPIN CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 | 43 | 0 |
| K831948 | LKB 2161 MIDISPIN R CENTRIFUGE | Lkb Instruments, Inc. | 1983-07-29 | 43 | 0 |
| K823049 | ENGSTROM ELIZA CO2 ANALYZER | Lkb Instruments, Inc. | 1983-01-12 | 89 | 0 |
| K821365 | ENGSTOM EDITH | Lkb Instruments, Inc. | 1982-06-29 | 53 | 0 |
| K821344 | ENGSTROM METABOLIC COMPUTER | Lkb Instruments, Inc. | 1982-05-28 | 23 | 0 |
| K820415 | 4150 ALPHA AMINO ACID ANALYZER | Lkb Instruments, Inc. | 1982-03-11 | 27 | 0 |
| K820273 | 4050/4051 ULTRASPEC | Lkb Instruments, Inc. | 1982-02-18 | 16 | 0 |
| K820217 | LKB-WALLACE 1251 LUMINOMETER | Lkb Instruments, Inc. | 1982-02-12 | 17 | 0 |
| K812642 | ENGSTROM ERICA | Lkb Instruments, Inc. | 1981-11-05 | 50 | 0 |
| K812158 | LKB-BROMMA 2188 ULTROTOME NOVA | Lkb Instruments, Inc. | 1981-09-16 | 49 | 0 |
| K812157 | LKB-BROMMA 2218 HISTORANGE MICROTOME | Lkb Instruments, Inc. | 1981-08-18 | 20 | 0 |
| K811019 | LKB 4460 FLUORIMETER | Lkb Instruments, Inc. | 1981-04-29 | 14 | 0 |
| K803131 | LKB-WALLACE 1250 LUMINOMETER | Lkb Instruments, Inc. | 1981-01-15 | 34 | 0 |
| K802614 | ENGSTROM EMMA ANESTHETIC GAS MONITOR | Lkb Instruments, Inc. | 1981-01-07 | 78 | 0 |
| K803004 | AMINO ACID ANALYSER SYSTEM | Lkb Instruments, Inc. | 1980-12-22 | 26 | 0 |
| K791297 | PRISMA | Lkb Instruments, Inc. | 1979-08-10 | 25 | 0 |
| K780340 | IMV SYSTEM | Lkb Instruments, Inc. | 1978-11-27 | 271 | 0 |
| K780341 | SCINTILLATION, LIQUID, RACKBETA | Lkb Instruments, Inc. | 1978-05-26 | 86 | 0 |
| K780344 | GAMMA COUNTER | Lkb Instruments, Inc. | 1978-04-12 | 42 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda