Isolab, Inc.
Mchenry, IL, US
Isolab, Inc. appears in FDA device records in Mchenry, IL. FDA records list 44 510(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
- 44
- PMA records
- 0
- Recall records
- 0
- Registered establishments
- 0
510(k) clearance history
FDA records hold 44 510(k) clearances for Isolab, Inc. between 1977 and 1996. The busiest year on record is 1981, with 4. The most recent is 1996, with 3.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 1 |
| 1978 | 2 |
| 1979 | 1 |
| 1980 | 3 |
| 1981 | 4 |
| 1982 | 2 |
| 1983 | 1 |
| 1984 | 4 |
| 1986 | 2 |
| 1988 | 2 |
| 1989 | 1 |
| 1990 | 3 |
| 1991 | 4 |
| 1992 | 2 |
| 1993 | 2 |
| 1994 | 3 |
| 1995 | 4 |
| 1996 | 3 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K951014 | ISOLAB'S T4 TEST KIT | KLI | Substantially Equivalent | |
| K950481 | NEONATAL CHEMISTRY SYSTEM, GALACTOSE TEST KIT | JIA | Substantially Equivalent | |
| K943547 | PHENYLALANINE TEST KIT | JNB | Substantially Equivalent | |
| K950803 | ISOLAB'S GALACTOSE-1-PHOSPHATE URIDYL TRANFERASE TEST KITS 800, 4000 SAMPLE | JJT | Substantially Equivalent | |
| K950415 | FLUOROSCAN NEONATAL | KHO | Substantially Equivalent | |
| K942276 | QUIK-SEP QUANTITATIVE HEMOGLOBIN S ASSAY | GIQ | Substantially Equivalent | |
| K942222 | QUIK-SEP QUANTITIVE HEMOGLOBIN S CONTROLS | JCM | Substantially Equivalent | |
| K944185 | ISOSCAN | JQT | Substantially Equivalent | |
| K934013 | RESOLVE SYSTEMS ALKALINE PHOSPHATASE TEST KIT | CIN | Substantially Equivalent | |
| K923153 | HEMOCARD, HEMOGLOBIN C ASSAY | MLL | Substantially Equivalent | |
| K931234 | HEMOCARD CONTROL HB-AA, AE, FAA, FAE | JCM | Substantially Equivalent | |
| K930070 | HEMOCARD HEMOGLOBIN E | CKA | Substantially Equivalent | |
| K924173 | HEMOCARD(TM) CONTROL | JCM | Substantially Equivalent | |
| K921681 | CRITERION, HEMOCUE B-HEMOGLOBIN CONTROL | GGM | Substantially Equivalent | |
| K911981 | HEMOCARD HEMOGLOBIN S | GHM | Substantially Equivalent | |
| K910430 | HEMOCARD-AS | GHM | Substantially Equivalent | |
| K910431 | HEMOCARD CONTROL | JCM | Substantially Equivalent | |
| K905513 | GLYC-AFFIN(TM)-GA | LCP | Substantially Equivalent | |
| K904814 | GLYC-AFFIN GP | LCP | Substantially Equivalent | |
| K902740 | LDL-DIRECT CONTROLS | JJY | Substantially Equivalent | |
| K901453 | QUIK-SEP(R) IGM RPROTEIN G AFFINITY METHOD | DFT | Substantially Equivalent | |
| K883411 | PG-NUMERIC(TM) | JHF | Substantially Equivalent | |
| K880673 | GHB SAMPLE PAPER | LCP | Substantially Equivalent | |
| K873428 | GLYCO-PROBE GSP | LCP | Substantially Equivalent | |
| K862638 | VISIBLE-CHLAMYDIA(TM) TEST SYSTEM | LJC | Substantially Equivalent | |
| K854712 | VISIBLE-HERPES TM TEST SYSTEM | GQO | Substantially Equivalent | |
| K843122 | RESOLVE-CSF | DFI | Substantially Equivalent | |
| K842152 | SICKLING HEMOGLOBIN CONTROLS, NORMAL | GHM | Substantially Equivalent | |
| K841170 | SICKLE HB ASSAY | GHM | Substantially Equivalent | |
| K840011 | RESOLVE-HB | GKA | Substantially Equivalent | |
| K830606 | QUIK-SEP IGM ISOLATION SYSTEM | DFT | Substantially Equivalent | |
| K822867 | GLYC-AFFIN GLYCOHEMOGLOBIN ASSAY | LCP | Substantially Equivalent | |
| K820630 | QUIK-SEP HEMOGLOBIN F ASSAY & CONTROL | JPC | Substantially Equivalent | |
| K812318 | LIPO-SEP CHOLESTEROL AUDIT SYSTEM | Substantially Equivalent | ||
| K810976 | ALPHA-THAL SCREEN TM CONTROL | LGL | Substantially Equivalent | |
| K810919 | HEMOGLOBIN ELECTROPHORESIS CONTROL | JBD | Substantially Equivalent | |
| K801771 | ALPHA-THAL SCREEN 20 TEST KIT & 100 KIT | LGL | Substantially Equivalent | |
| K802997 | HDL-CHOLESTEROL CONTROL SERUM | JJX | Substantially Equivalent | |
| K801410 | HEMOHLOBIN A2 CONTROL-LYOPHILIZED | JPD | Substantially Equivalent | |
| K800794 | FAST HEMOGLOBIN CONTROL-LYOPHILIZED | LCP | Substantially Equivalent | |
| K791143 | SICKLE-CELL F TEST | KQI | Substantially Equivalent | |
| K781851 | HEMOGLOBIN, TESTING SYSTEM | LCP | Substantially Equivalent | |
| K780998 | SCALPEL | GDX | Substantially Equivalent | |
| K771649 | HEMOGLOBIN A2 TESTING SYSTEM | JBD | Substantially Equivalent |
Registered establishments
No FDA establishment registrations recorded against this company.
FDA product codes
- GKAAbnormal Hemoglobin Quantitation
- GQOAntisera, Cf, Herpesvirus Hominis 1,2
- LGLAssay, Bart'S, Hemoglobin
- KQIAssay, Fetal Hemoglobin
- LCPAssay, Glycosylated Hemoglobin
- JHFColorimetric Method, Lecithin/Sphingomyelin Ratio
- GGMControl, Hemoglobin
- JCMControl, Hemoglobin, Abnormal
- JQTDensitometer/Scanner (Integrating, Reflectance, Tlc, Radiochromat.) Clinica
- CINElectrophoretic Separation, Alkaline Phosphatase Isoenzymes
- JIAEnzymatic Methods, Galactose
- JJTEnzyme Controls (Assayed And Unassayed)
- KLIEnzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
- LJCEnzyme Linked Immunoabsorbent Assay, (Chlamydiae Group)
- KHOFluorometer, For Clinical Use
- JPDHemoglobin A2 Quantitation
- MLLHemoglobin C (Abnormal Hemoglobin Variant)
- JPCHemoglobin F Quantitation
- GIQHemoglobin S
- DFTIgm, Antigen, Antiserum, Control
- JJYMulti-Analyte Controls, All Kinds (Assayed)
- CKANadh Oxidation/Nad Reduction, Alt/Sgpt
- JNBNinhydrin And L-Leucyl-L-Alanine (Fluorimetric), Phenylalanine
- GDXScalpel, One-Piece
- JJXSingle (Specified) Analyte Controls (Assayed And Unassayed)
- JBDSystem, Analysis, Electrophoretic Hemoglobin
- GHMTest, Sickle Cell
- DFITotal Spinal-Fluid, Antigen, Antiserum, Control
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