Analytical Products, Inc.
Mchenry, IL, US
Analytical Products, Inc. appears in FDA device records in Mchenry, IL. FDA records list 57 510(k) clearances between and , 11 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
- 57
- PMA records
- 11
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
Showing 50 of 57FDA records hold 57 510(k) clearances for Analytical Products, Inc. between 1976 and 1993. The busiest year on record is 1983, with 12. The most recent is 1993, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1976 | 1 |
| 1977 | 5 |
| 1978 | 3 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 3 |
| 1982 | 6 |
| 1983 | 12 |
| 1984 | 5 |
| 1985 | 3 |
| 1986 | 2 |
| 1987 | 4 |
| 1988 | 3 |
| 1989 | 1 |
| 1990 | 2 |
| 1992 | 2 |
| 1993 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K924814 | API 20E/UNISCEPT 20E | JSS | Substantially Equivalent | |
| K923684 | API UNISCEPT MIC/TYPE 2 AND 3 AND MICRO MIC | JWY | Substantially Equivalent | |
| K922926 | API UNISCEPT KB/TYPE 2 AND 3 | JWY | Substantially Equivalent | |
| K901559 | MODIFICATION TO API UNISCEPT 20GP | LQL | Substantially Equivalent | |
| K901390 | DMAC INDOLE REAGENT | JTO | Substantially Equivalent | |
| K895796 | API UNISCEPT KB | JWY | Substantially Equivalent | |
| K884510 | MODIFICATION MICRO-MIC | JWY | Substantially Equivalent | |
| K884509 | MODIFICATION MIC/API UNISCEPT(R) | JWY | Substantially Equivalent | |
| K880598 | MODIFICATIONS TO API UNISCEPT (R) KB | JWY | Substantially Equivalent | |
| K874466 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT MIC | JWY | Substantially Equivalent | |
| K865062 | ALADIN (TM) | LRG | Substantially Equivalent | |
| K870663 | API UNISCEPT(R) MICRO-MIC(R) SYSTEM/UNISCEPT(R)MIC | JWY | Substantially Equivalent | |
| K864891 | API UNISCEPT (TM) KB | JWY | Substantially Equivalent | |
| K862543 | DYNEX CO2/2000, CO2 ANALYZER | CCK | Substantially Equivalent | |
| K860369 | API UNISCEPT MICRO-MIC CEFTRIAXONE/UNISCEPT MIC | JWY | Substantially Equivalent | |
| K853544 | QUAD FERM + | JSX | Substantially Equivalent | |
| K850982 | CTAPI - NEISSERA SCREEN | JSE | Substantially Equivalent | |
| K850347 | API UNISCEPT KB | LTW | Substantially Equivalent | |
| K844159 | API UNISCEPT MIC 100UL | LTW | Substantially Equivalent | |
| K843360 | ARTAP ARTERIAL BLOOD SAMPLING DEVICE | CBT | Substantially Equivalent | |
| K843733 | API UNISCEPT KB | LTW | Substantially Equivalent | |
| K843732 | API UNISCEPT MIC | LTD | Substantially Equivalent | |
| K842839 | SERIMM SURE ASO-CHEK CONTROL SERUM | GTQ | Substantially Equivalent | |
| K833988 | API STAPHASE III | JTL | Substantially Equivalent | |
| K832981 | ELECTRODES FOR BLOOD GAS ANALYZERS | CHL | Substantially Equivalent | |
| K832779 | REFEREE BLOOD GAS ANALYZER-ELECTRODES | CHL | Substantially Equivalent | |
| K831462 | API UNISCEPT PLUS 140 INOCULATOR | JTC | Substantially Equivalent | |
| K831341 | API UNISCEPT PLUS AUTOINOCULATOR | JTC | Substantially Equivalent | |
| K830525 | API 20GP | JSE | Substantially Equivalent | |
| K831032 | API ANAIDENT | JSP | Substantially Equivalent | |
| K830180 | REFEREE BRAND CO-OXIMETER REAGENTS | KHG | Substantially Equivalent | |
| K830286 | YEAST IDENT | JXB | Substantially Equivalent | |
| K830211 | API TB-IDENT* | JSY | Substantially Equivalent | |
| K830181 | REFEREE BLOOD GAS ANALYZER CONTROLS | JJS | Substantially Equivalent | |
| K823785 | API MDS* | JQP | Substantially Equivalent | |
| K821907 | NEIDENT* | JTO | Substantially Equivalent | |
| K821338 | SALMONELLA I.D. | GRM | Substantially Equivalent | |
| K821337 | SHIGELLA I.D. | GNB | Substantially Equivalent | |
| K821339 | SALMONELLA POLY | GEN | Substantially Equivalent | |
| K820786 | ASO SURE PLUS | GTQ | Substantially Equivalent | |
| K820785 | ASO SURE | GTQ | Substantially Equivalent | |
| K811998 | STAPH-IDENT | JTO | Substantially Equivalent | |
| K811982 | STAPHASE* | JTL | Substantially Equivalent | |
| K810762 | API TURBICITY STANDARD | JKP | Substantially Equivalent | |
| K801951 | API-CTS STREPTOCOCCUS | JTO | Substantially Equivalent | |
| K792447 | REFEREE BFT BLOOD FOR TONOMETRY | JJS | Substantially Equivalent | |
| K791222 | API 20E REAGENT QC | JSE | Substantially Equivalent | |
| K790281 | DIAGNOSTIC SET, LIPO-FRAX | LBS | Substantially Equivalent | |
| K781567 | API ZYM | JTO | Substantially Equivalent | |
| K781283 | READER, INOCULUM, STDIZED. | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase
- GRMAntisera, All Groups, Salmonella Spp.
- GNBAntisera, All Types, Shigella Spp.
- GTQAntistreptolysin - Titer/Streptolysin O Reagent
- CBTArterial Blood Sampling Kit
- JQPCalculator/Data Processing Module, For Clinical Use
- JISCalibrator, Primary
- JKPChromium-51, Blood Volume
- JJSControls For Blood-Gases, (Assayed And Unassayed)
- JSECulture Media, Multiple Biochemical Test
- JTCDevice, Microtiter Diluting/Dispensing
- JTODiscs, Strips And Reagents, Microorganism Differentiation
- CHLElectrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- GENForceps, General & Plastic Surgery
- LQLGram Positive Identification Panel
- LRGInstrument For Auto Reader & Interpretation Of Overnight Suscept. Systems
- JSPKit, Anaerobic Identification
- JSSKit, Identification, Enterobacteriaceae
- JSYKit, Identification, Mycobacteria
- JSXKit, Identification, Neisseria Gonorrhoeae
- JXBKit, Identification, Yeast
- LBSLdl & Vldl Precipitation, Cholesterol Via Esterase-Oxidase, Hdl
- JWYManual Antimicrobial Susceptibility Test Systems
- LTDParaquat Assay
- JTLPlasma, Coagulase, Human, Horse And Rabbit
- LTWSusceptibility Test Cards, Antimicrobial
- LONSystem, Test, Automated, Antimicrobial Susceptibility, Short Incubation
- KHGWhole Blood Hemoglobin Determination
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