Lkb Instruments, Inc.
Mchenry, IL, US
Lkb Instruments, Inc. appears in FDA device records in Mchenry, IL. FDA records list 52 510(k) clearances between and , no PMA records and no registered establishments. As of , FDA records show no recalls for this company.
FDA records held for this company
- 510(k) clearances
- 52
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 52FDA records hold 52 510(k) clearances for Lkb Instruments, Inc. between 1976 and 1987. The busiest year on record is 1986, with 8. The most recent is 1987, with 7.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1978 | 4 |
| 1979 | 1 |
| 1980 | 1 |
| 1981 | 6 |
| 1982 | 5 |
| 1983 | 5 |
| 1984 | 7 |
| 1985 | 7 |
| 1986 | 8 |
| 1987 | 7 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K874094 | 1205 BETAPLATE LIQUID SCINTILLATION COUNTER | JJJ | Substantially Equivalent | |
| K872955 | DELFIA(TM) FERRITIN KIT | JMG | Substantially Equivalent | |
| K871303 | DELFIA(TM) THYROXINE (T4) KIT | CDX | Substantially Equivalent | |
| K871599 | DELFIA(TM) HIGE KIT | DHB | Substantially Equivalent | |
| K871644 | DELFIA (TM) HTSH KIT | JLW | Substantially Equivalent | |
| K864452 | DELFIA(TM) TRIIODOTHYRONINE (T3) KIT | CDP | Substantially Equivalent | |
| K864733 | LKB 2260 MACROTOME | IDO | Substantially Equivalent | |
| K862848 | LKB ULTROBACT (TM) PNEUMOCOCCUS KIT; 2321-110 | GWC | Substantially Equivalent | |
| K863422 | DELFIA(TM) CORTISOL KIT | JFT | Substantially Equivalent | |
| K862044 | DELFIA (TM) HCG KIT | JHJ | Substantially Equivalent | |
| K861195 | DELFIA DIGOXIN | KXT | Substantially Equivalent | |
| K862043 | DELFIA (TM) HFSH KIT | CGJ | Substantially Equivalent | |
| K861542 | DELFIA (TM) HUMAN PROLACTIN | CFT | Substantially Equivalent | |
| K861194 | ULTROSPEC K KINETICS SPECTROPHOTOMETER | JJQ | Substantially Equivalent | |
| K855173 | DELFIA TM HLH KIT | CEP | Substantially Equivalent | |
| K852760 | LBK 1244 DELFIA HCG KIT | JHI | Substantially Equivalent | |
| K852538 | LKB 4057 ULTROSPEC II E | JJQ | Substantially Equivalent | |
| K852434 | 1208 BETACORD AND 1208 BETCORD M | JJJ | Substantially Equivalent | |
| K851120 | DELFIA HTSH KIT | JLW | Substantially Equivalent | |
| K851984 | LKB-WALLAC 1230 ARCUS FLUOROMETER | KHO | Substantially Equivalent | |
| K851572 | NOVASPEC VISIBLE SPECTROPHOTOMETER | JJQ | Substantially Equivalent | |
| K844413 | ULTROSER G | JJY | Substantially Equivalent | |
| K844164 | REACTIFS, IBF ULTROGELS ACA & ULTROGELS A | DII | Substantially Equivalent | |
| K843506 | LKB 2189 ULTROPROCESSOR | IEO | Substantially Equivalent | |
| K843505 | LKB 2230 ROTARY ONE | IDO | Substantially Equivalent | |
| K842028 | CM-TRISACRYL M DEAE-TRISACRYL M | KEA | Substantially Equivalent | |
| K834490 | GELSCAN SOFTWARE 2190 | JQP | Substantially Equivalent | |
| K840985 | TRISACRYL GF 05 & TRISACRYL GF 2000 | DJY | Substantially Equivalent | |
| K834489 | ULTROSPEC W/APPLE II -4050- | JJQ | Substantially Equivalent | |
| K830797 | IMMOBILINE SYSTEM LKB 1819 | JJN | Substantially Equivalent | |
| K831948 | LKB 2161 MIDISPIN R CENTRIFUGE | JQC | Substantially Equivalent | |
| K831947 | LKB 2160 MIDISPIN CENTRIFUGE | JQC | Substantially Equivalent | |
| K831942 | LKB 2164 MACRO-SPIN R CENTRIFUGE | JQC | Substantially Equivalent | |
| K823049 | ENGSTROM ELIZA CO2 ANALYZER | CCK | Substantially Equivalent | |
| K821365 | ENGSTOM EDITH | BYD | Substantially Equivalent | |
| K821344 | ENGSTROM METABOLIC COMPUTER | BZL | Substantially Equivalent | |
| K820415 | 4150 ALPHA AMINO ACID ANALYZER | JJF | Substantially Equivalent | |
| K820273 | 4050/4051 ULTRASPEC | JJQ | Substantially Equivalent | |
| K820217 | LKB-WALLACE 1251 LUMINOMETER | JJQ | Substantially Equivalent | |
| K812642 | ENGSTROM ERICA | CBK | Substantially Equivalent | |
| K812158 | LKB-BROMMA 2188 ULTROTOME NOVA | IDM | Substantially Equivalent | |
| K812157 | LKB-BROMMA 2218 HISTORANGE MICROTOME | IDO | Substantially Equivalent | |
| K811019 | LKB 4460 FLUORIMETER | KHO | Substantially Equivalent | |
| K803131 | LKB-WALLACE 1250 LUMINOMETER | JJQ | Substantially Equivalent | |
| K802614 | ENGSTROM EMMA ANESTHETIC GAS MONITOR | CBS | Substantially Equivalent | |
| K803004 | AMINO ACID ANALYSER SYSTEM | JJF | Substantially Equivalent | |
| K791297 | PRISMA | JJE | Substantially Equivalent | |
| K780340 | IMV SYSTEM | CBD | Substantially Equivalent | |
| K780341 | SCINTILLATION, LIQUID, RACKBETA | JJJ | Substantially Equivalent | |
| K780344 | GAMMA COUNTER | JJJ | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- JHJAgglutination Method, Human Chorionic Gonadotropin
- JJEAnalyzer, Chemistry (Photometric, Discrete), For Clinical Use
- JJFAnalyzer, Chemistry, Micro, For Clinical Use
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- CBSAnalyzer, Gas, Halothane, Gaseous-Phase (Anesthetic Conc.)
- GWCAntisera, All Types, Streptococcus Pneumoniae
- JJNApparatus, Electrophoresis, For Clinical Use
- CBDBottle, Collection, Breathing System (Calibrated)
- JQPCalculator/Data Processing Module, For Clinical Use
- JQCCentrifuges (Micro, Ultra, Refrigerated) For Clinical Use
- JJQColorimeter, Photometer, Spectrophotometer For Clinical Use
- DIIColumns, Glc
- BZLComputer, Oxygen-Uptake
- BYDCondenser, Heat And Moisture (Artificial Nose)
- JJJCounter (Beta, Gamma) For Clinical Use
- KXTEnzyme Immunoassay, Digoxin
- KHOFluorometer, For Clinical Use
- JFTFluorometric, Cortisol
- DJYIon-Exchange Chromatography
- IDOMicrotome, Rotary
- IDMMicrotome, Ultra
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- IEOProcessor, Tissue, Automated
- JMGRadioimmunoassay (Two-Site Solid Phase), Ferritin
- CGJRadioimmunoassay, Follicle-Stimulating Hormone
- CEPRadioimmunoassay, Luteinizing Hormone
- CFTRadioimmunoassay, Prolactin (Lactogen)
- JLWRadioimmunoassay, Thyroid-Stimulating Hormone
- CDXRadioimmunoassay, Total Thyroxine
- CDPRadioimmunoassay, Total Triiodothyronine
- DSFRecorder, Paper Chart
- KEAResins, Ion-Exchange
- DHBSystem, Test, Radioallergosorbent (Rast) Immunological
- CBKVentilator, Continuous, Facility Use
- JHIVisual, Pregnancy Hcg, Prescription Use
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain